WO2013186702A1 - Method and kit for making surgical templates for dental implantation - Google Patents

Method and kit for making surgical templates for dental implantation Download PDF

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Publication number
WO2013186702A1
WO2013186702A1 PCT/IB2013/054779 IB2013054779W WO2013186702A1 WO 2013186702 A1 WO2013186702 A1 WO 2013186702A1 IB 2013054779 W IB2013054779 W IB 2013054779W WO 2013186702 A1 WO2013186702 A1 WO 2013186702A1
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WO
WIPO (PCT)
Prior art keywords
real
virtual
reference pin
model
pin
Prior art date
Application number
PCT/IB2013/054779
Other languages
French (fr)
Inventor
Marco AGUZZI
Alessandro MOTRONI
Original Assignee
Evoguide S.R.L.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Evoguide S.R.L. filed Critical Evoguide S.R.L.
Priority to EP13744819.7A priority Critical patent/EP2858590A1/en
Publication of WO2013186702A1 publication Critical patent/WO2013186702A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C1/00Dental machines for boring or cutting ; General features of dental machines or apparatus, e.g. hand-piece design
    • A61C1/08Machine parts specially adapted for dentistry
    • A61C1/082Positioning or guiding, e.g. of drills
    • A61C1/084Positioning or guiding, e.g. of drills of implanting tools
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10Computer-aided planning, simulation or modelling of surgical operations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101Computer-aided simulation of surgical operations
    • A61B2034/102Modelling of surgical devices, implants or prosthesis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/108Computer aided selection or customisation of medical implants or cutting guides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C2201/00Material properties
    • A61C2201/005Material properties using radio-opaque means

Definitions

  • the present invention relates to a method and a kit for making surgical templates for dental implantation.
  • a surgical template for dental implantation is a device enabling the dental surgeon to correctly position and realise, by drilling into the bone structure of a patient, at least a bore that can receive a dental implant.
  • a known solution is to produce surgical templates for virtual planning, with the aid of evolved software programs which process images detected by optical systems and/or TACs of the patient's mouth and/or models thereof.
  • the real template is then constructed using various methods (for example by prototyping or milling) starting from the digital model.
  • public document WO 03/060825 describes a method for producing a corrected digital image, without the artifacts, of a negative impression of the upper/lower jaw of a patient.
  • This method includes constructing a real/concrete negative impression of the patient's jaw; producing a first digital image of the real/concrete negative impression; producing a second digital image of the real/concrete negative impression installed in the patient's jaw; using the first digital image in order to reconstruct the outline of the second digital image distorted by the artifacts, so as to obtain a computer representation, free of the artifacts, of the negative impression of the patient's jaw.
  • the corrected digital image is then manipulated on the computer so as to add the guide bores of the plant and obtain a virtual template and, via a modeling process with a rapid prototyping machine, lastly generating the real surgical template.
  • Document WO2008/045965 describes a method for realising surgical templates for guiding drills during the steps of inserting a dental plant, comprising use of a virtual model of the upper/lower jaw of the patient.
  • Document FR2916958 illustrates a manufacturing process of a template for fixing a dental plant. Aim of the Invention
  • the Applicant has therefore recognised the need to provide a method and a kit for making surgical templates for dental implantation which are economical, simple to actuate/use and which enable concretely constructing the template directly by the dentist or the technicians present in the surgery, without the need to use external manufacturing centres.
  • the templates obtained will obviously have to guarantee excellent precision in locating the implantation in the patient's mouth during the surgical operation.
  • the invention relates to a method for making surgical templates for dental implantations, comprising:
  • preparing a real model of at least a portion of the upper/lower jaw of a patient ii. placing in an implant site of said real model at least one real reference pin having one real reference radiopaque portion mounted removably on an end of the real reference pin and emerging from said implant site;
  • the adjective “real” is taken to mean a concrete and material object.
  • the adjective “virtual” is understood to mean an electronic object reproduced on a computer.
  • the real model of the portion of the upper/lower jaw of a patient reproduces the existing dentition and the tissues and is preferably a plaster cast obtained using known techniques (a model of the impression taken from the patient) or a model originating from an intra-oral scan realized using rapid prototyping or milling techniques.
  • the implantation site is a zone in the real model (and the portion of the upper/lower jaw of the patient) in which an implant is to be inserted on which a dental prosthesis will be fixed.
  • the real reference pin is made of metal.
  • the radiopaque reference portion is made of plastic and is mounted preferably removably on an end of the real reference pin.
  • the real radiological template is preferably manually constructed with resin.
  • the resin is first applied on the real model, such as to partially sink the radiopaque reference portion, and then a bite is applied on the resin to gauge the occlusion.
  • the bite, the consolidated resin and the radiopaque reference portion, which form the radiological template, are then inserted into the patient's mouth.
  • the vertical model acquired by means of tomography comprises the virtual model of the bone structure of the upper/lower jaw of the patient and the virtual model of the radiopaque reference portion.
  • the virtual reference pin is generate by means of a software program in the virtual model acquired by means of tomography and the position of the virtual reference pin in the virtual model is identified by the position of the virtual radiopaque reference portion.
  • the virtual reference pin preferably reproduces the structure of the real plant (which typically exhibits a profile of a threaded pin) which will have to be inserted in the patient's bone.
  • the relative position of the virtual reference pin with respect to the virtual radiopaque reference portion in the virtual model is the same relative position of the real reference pin with respect to the radiopaque reference portion in the real plaster model.
  • the bone structure is visible, it is possible to verify, even if only visually on the monitor, if the virtual reference pin is located correctly therein or it is too close to the limit of the bone or even exceeds it.
  • the surgical template is preferably constructed manually with photo- polymerisable resin in such a way that it embeds the guide sleeve.
  • step vii. and before step viii. the position of the virtual reference pin in the virtual model is kept unchanged and the support element is selected such as to maintain the guide sleeve aligned to the real reference pin.
  • the dentist has inserted the real reference pin thus enables (once the guide sleeve becomes part of the surgical template which is formed about it) drilling a hole in the correct position in the patient corresponding to the position of the real reference pin in the plaster model.
  • step vii. and before step viii. the position of the virtual reference pin in the virtual model is adjusted and the support element is selected so as to vary the position of the guide sleeve with respect to the real reference pin according to the correction of the position of the virtual reference pin.
  • the virtual position is wrong it means that the dentist has inserted the real reference pin in the real model with a positioning error. The positioning is corrected in the virtual model.
  • the selected support element is installed on the end of the real reference pin, in place of the radiopaque reference portion, displaces the guide sleeve (translation and rotation) from the original position, in which it would have produced a hole in the position (wrong) corresponding to the position of the real reference pin in the real model, to the new virtually-identified position, in which it produces a hole in the position (correct) corresponding to the position of the correct virtual reference pin in the virtual model.
  • the virtual reference pin in the virtual model is preferably displaced into the occlusal plane and the support element exhibits at least a varying element of the occlusal position corresponding to the displacement of the virtual reference pin.
  • the virtual reference pin in the virtual model is preferably rotated and the support element exhibits at least a varying element of the angular position corresponding to the rotation of the virtual reference pin.
  • the virtual reference pin in the virtual model is preferably translated along the longitudinal axis thereof and a spacer is selected for regulating the depth of the milling on the patient corresponding to the translation of the virtual reference pin.
  • the correction is not made by means of an appropriate support element for the guide sleeve but by correcting the depth of the milling by means of a spacer to be installed on the miller itself when working on the patient.
  • this correct might, like the others, be obtained by means of an appropriate shape/dimension of the support element.
  • the invention relates to a kit for making surgical plates for dental implantation according to the above-described method, comprising:
  • At least one real reference pin having one radiopaque reference portion having one radiopaque reference portion; a support element for guide sleeves capable of being installed on the real reference pin instead of the radiopaque reference portion.
  • the support element preferably comprises an element for changing the occlusal position and/or an element for changing the angular position.
  • the support elements are preferably of the single-use type.
  • the element for changing the occlusal position preferably comprises a body exhibiting a cam seat and installable offset on an end of the real reference pin.
  • the element for changing the occlusal position preferably comprises a cylindrical body installable on an end of the real reference pin with a longitudinal axis thereof inclined with respect to the longitudinal axis of the real reference pin.
  • Various types of elements for varying the occlusal position are preferably available, as well as various types of elements for varying the angular position, inter-combinable to form the appropriate support element.
  • the pin, the element for varying the occlusal position and the element for varying the angular position are joined by gluing.
  • the pin, the element for varying the occlusal position and the element for varying the angular position are joined by jointing, preferably with a snap-fit. This guarantees greater cleanliness and hygiene with respect to the glued solution.
  • the choice of the elements and the spacer for the miller is preferably done automatically by a software program, on the basis of the virtual correction of the position of the virtual reference pin in the virtual model, and is recommended to the user.
  • the elements are distinguished by different colouring.
  • the coupling of the elements for varying is preferably done by jointing.
  • the kit pins, elements for varying the occlusal and angular position, spacers
  • the kit is preferably sold as a complete kit together with the software, resin/s, silicone for the bit, milling bits.
  • the kit does not comprise the elements for varying the occlusal and angular position, combinable with one another, but the software, starting again from the displacement of the virtual pin, is able to virtually generate the suitable and customised support element (or the single elements for varying the position).
  • the 3D file of the support element is sent to a specialized centre where from the virtual support element, and via a rapid prototyping or milling, the real support element is realized and sent to the dental surgery.
  • the Applicant has found that the method and kit of the invention enable newly reducing costs and also reducing production times for the surgical templates, in particular for rehabilitating partially edentate dental arches.
  • the Applicant has found that the method and kit of the invention enable newly reducing costs and also reducing production times for the surgical templates, in particular for rehabilitating partially edentate dental arches.
  • FIG. 1 a to 3a schematically illustrate a front view of a real model of a portion of an upper/lower jaw in a sequence of steps according to the method of the invention
  • FIG. 1 b to 3b schematically illustrate a lateral view of the same real model of the first sequence of figures 1 a to 3a;
  • FIGS. 4a and 4b schematically illustrate, respectively in a front view and a lateral view, a radiological guide obtained with the method of the invention
  • FIGS. 5a and 6a schematically illustrate a front view of a virtual model of a portion of an upper/lower jaw in a sequence of steps according to the method of the invention
  • FIGS. 5b and 6b schematically illustrate a lateral view of the same virtual model in the same sequence as in figures 5a and 6a;
  • FIG. 7 to 10 schematically illustrate the lateral view of figures 5b and 6b in a further sequence of steps according to the method of the invention
  • FIG. 1 schematically illustrate the lateral view of the real model of figures from 1 b to 3b in a further sequence of steps according to the method of the invention
  • figure 14 is a front view of the real model on which the surgical template of the method of the invention has been made
  • figure 15 illustrates a first element of the kit according to the invention
  • figure 16 illustrates a set of second elements of the kit of the invention
  • figure 17 illustrates a third element of the kit of the invention
  • figure 18 illustrates the second and third element of figures 16 and 17, associated to form a support element arranged on the first element
  • figure 19 illustrates a fourth element of the kit associated to the support element of figure 18;
  • figure 20 illustrates a fifth element of the kit of the invention
  • the kit of the invention comprises a plurality of real reference pins 1 made of metal.
  • Each of the pins 1 (figures 15 and 21 ) exhibits a first portion 1 a intended to be inserted in a real model of a portion of the upper/lower jaw of a patient and an end portion 1 b designed to protrude from the cast.
  • the end portion 1 b exhibits a polygonal section, preferably square.
  • the end portion 1 b is circular and includes a pair of hooks 14 that protrude from an end surface of the end portion 1 b thereof.
  • the kit comprises a plurality of radiopaque reference portions 2 (one of which is illustrated in detail in figure 20) made of plastic material, each provided with an engaging seat with the end 1 b of the pin 1 and suitably shaped to securely grip with a resin material in which it is destined to be partially incorporated and to be precisely detected by means of tomography.
  • the kit includes various types of an element for varying an occlusal position 3 (three of which are illustrated in figure 16 and figure 22), which comprises a body affording a seat 3a installable on an end 1 b of the real reference pin 1 in place of the radiopaque reference portion 2, according to the method described in the following.
  • this body is a disc provided with a through-hole which defines the seat 3a.
  • the various types are distinguished by a different position of the seat 3a, more or less centred on the disc.
  • the disc also exhibits a plurality of peripheral recesses 3b.
  • the disc has three hooks 15 that protrude from an upper surface of the disc itself and an edge in relief 16 inside the seat 3a (only visible in figure 24) is intended to serve as a foothold for the hooks 14 of the end portion 1 b of the pin 1 .
  • the kit includes various types of an element for varying the angular position 4 (only one shown in figure 17 and, in an alternative embodiment, in figure 23).
  • the element for varying the angular position 4 comprises a cylindrical body provided with a base 4a from which positioning pins 4b extend.
  • the cylindrical body is positionable on the end 1 b of the real reference pin 1 with the base 4a thereof resting against the disc of the element for varying the occlusal position 3 and each of the pins 4b housed in one of the peripheral recesses 3b (figure 18).
  • the various types are characterized by a different inclination of the axis of symmetry "X-X" of the cylindrical wall 4c with respect to the base 4a which corresponds to a different angle formed between the axis of symmetry "X-X" of the cylindrical wall 4c and a longitudinal axis ⁇ - ⁇ " of the real reference pin 1 (figure 18).
  • the element for varying the angular position 4 can be mounted on the element for varying the occlusal position 3 in various angular positions, rotated about the longitudinal axis ⁇ - ⁇ " of the pin 1 , or an axis parallel thereto, simply by changing the peripheral recesses 3b in which the pins 4b are housed.
  • the cylindrical body is not provided with the positioning pins 4b but affords a star-shaped hole 17 in the base 4a and an internal edge 18 intended to serve as an entry for the hooks 15 of the element for varying the occlusal position 3 (better viewed in figure 24).
  • the element for varying the angular position 4 can be mounted on the element for varying the occlusal position 3 in various angular positions, rotated about the longitudinal axis ⁇ - ⁇ " of the pin 1 or an axis parallel thereto, simply by passing the hooks 15 through different arms of the star-shaped opening 17.
  • a plug 19 advantageously closes the upper opening of the cylindrical body of the element for varying the angular position 4.
  • the cap 19 can include a color- code for easy identification of the correct angle of the installed element for varying the angular position 4.
  • the kit comprises a plurality of metal guide sleeves 5, each fittable around the cylindrical wall 4c (as shown in figure 19 and, in a variant, in figure 25).
  • the kit also includes materials for manual realisation of surgical and radiographic templates, such as resin and silicone bites, milling bits and spacers for changing and regulating the milling depth.
  • materials for manual realisation of surgical and radiographic templates such as resin and silicone bites, milling bits and spacers for changing and regulating the milling depth.
  • a mould is made of the patient's mouth and a real model 6, made of plaster, is then made of the interested portion, which cast therefore reproduces existing teeth 6a and the gingival tissue 6b (schematically illustrated in figures 1 a , 2a, 3a, 1 b, 2b, 3b).
  • an intra-oral scan is performed on the mouth and a model made using RP techniques or milling.
  • the dentist inserts one of the pins 1 (figures 1 a and 1 b) in the zone where the implant is to be made for the prosthesis (which in the attached figures consists of only one tooth), taking care to leave the end 1 b protruding from the real model 6. Since the real model reproduces the visible part of the mouth, the dentist cannot know if the pin 1 is positioned correctly in the bone.
  • the dentist applies one of the portions of radiopaque reference 2 (figures 2a and 2b) on the end 1 b of the real reference pin 1 and then applies the resin 7 (e.g. transparent white) on the real model 6, partially incorporating the radiopaque reference portion 2 (figures 3a and 3b). A bite made of polymer material is then applied on the resin (not illustrated).
  • the resin 7 e.g. transparent white
  • the bite (not illustrated) and the polymerized resin 7 form, together with the radiopaque reference portion 2, a radiological template 8 (figures 4a and 4b) which is separated from the real model 6 (in which the real reference pin 1 remains, no longer having the radiopaque reference portion 2) and inserted into the patient's mouth.
  • the patient with the radiological template 8 is subjected to CT tomography scan and a 3D virtual (virtual model 9) is generated of the bone structure 10' of the portion of the upper/lower jaw interested by the implantation and the radiopaque reference portion 2' (figures 5a and 5b).
  • This virtual model 9 differs from the real model 6 in that in teeth 6a' and bone 10' are represented in it, but not the soft tissue (gums).
  • the virtual model 9 is manipulated using software and the software is also used to generate and position a virtual reference pin 1 ', which reproduces the geometry of the real plant that will be inserted in the patient's model and which will serve to support the prosthesis (in figures 6a and 6b it is schematically represented).
  • the virtual reference pin V is positioned, with respect to the virtual radiopaque reference portion 2', in the same relative position between the real reference pin 1 and the real radiopaque reference portion 2.
  • the dentist is now in a position to verify, on the virtual model 9, whether the position of the virtual reference pin 1 ' in the virtual bone 10' is correct or not.
  • Figure 7 illustrates an incorrect position; in fact the virtual reference pin 1 ' exits from the bone 10' and is too inclined.
  • the dentist corrects the position of the virtual reference pin 1 ' in the virtual bone 10' until it is in the correct position.
  • the virtual reference pin 1 ' is first shifted towards the right (figure 8) then rotated until it is substantially perpendicular to the occlusal plane (figure 9); then it is translated vertically (figure 10).
  • the elements of the kit (pin 1 , element for varying the occlusal position 3 and the element for varying the angular position 4) are mutually bonded.
  • the elements of the embodiment illustrated in figures 21 -25 are advantageously reciprocally jointed and cannot be separated without being broken.
  • the hooks 14 of the pin 1 inserted in the seat 3a snap- engage with the relief 16 of the element for varying the occlusal position 3.
  • the hooks 15 of the element for varying the occlusal position 3 snap-engage with the internal edge 18 of the element for varying the angular position 4.
  • the guide sleeve 5 which is installed on the element for varying the angular position 4 (figures 13, 19 or 25) is thus able to guide a tip of a milling bit in the direction of the virtual reference pin 1 ', which is corrected with respect to the direction of the real reference pin 1 .
  • the vertical correction or depth correction of the milling is, on the other hand, obtained by using a suitable spacer for the tip of the miller (not illustrated inasmuch of known type).
  • the software having the performed spatial correction as input, provides as output the correct combination or combinations of the elements for varying 3, 4 and the spacer.
  • the dentist assembles one of the elements for varying the occlusal position 3 with one of the elements for varying the angular position 4, as suggested by the software, such as to form a support element 1 1 on which the guide sleeve 5 is engaged.
  • the dentist or dental technician constructs the surgical template 13 with the resin 12 around the guide sleeve 5 and 6 above the real model the surgical guide 13, which template 13 will then be applied in the patient's mouth in order to drill the hole intended to receive the implant in the correct place.
  • the support element 1 1 and the real reference pin 1 remain in the real model as a prosthetic reference for the laboratory.

Abstract

The present invention relates to a method for realising surgical templates for dental implantation, which comprises: preparing a real model (6), being a plaster cast, of at least a portion of the upper/lower jaw of a patient and locating, in the real model (6), a reference pin (1) exhibiting a radiopaque reference portion (2); forming on the real model (6) a radiological template (8) encompassing at least part of said radiopaque reference portion (2); removing the radiological template (8) from the model (6) and inserting the template (6) in the patient's mouth and subjecting the patient to tomography in order to acquire a virtual model (9) of the portion of the upper/lower jaw of the patient and of the radiopaque reference portion (2'); generating, in the virtual model (9), a virtual reference pin (V) corresponding to the position of the virtual radiopaque reference portion (2'); correcting the position of the virtual reference pin (V) in the virtual model (9); installing at least a support element (11) for a guide sleeve (5) on the reference pin (1); installing the guide sleeve (5) on the support element (11) and forming, on the real model (6), a real surgical template (13) provided with the guide sleeve (5). The support element (11) is chosen such as to vary the position of the guide sleeve (5) with respect to the reference pin (1) according to the correction of the position of the virtual reference pin (1').

Description

"Method and Kit for Making Surgical Templates for Dental Implantation"
DESCRIPTION Field of the Invention
The present invention relates to a method and a kit for making surgical templates for dental implantation.
Prior Art
As is known, a surgical template for dental implantation is a device enabling the dental surgeon to correctly position and realise, by drilling into the bone structure of a patient, at least a bore that can receive a dental implant.
A known solution is to produce surgical templates for virtual planning, with the aid of evolved software programs which process images detected by optical systems and/or TACs of the patient's mouth and/or models thereof. The real template is then constructed using various methods (for example by prototyping or milling) starting from the digital model.
For example, public document WO 03/060825 describes a method for producing a corrected digital image, without the artifacts, of a negative impression of the upper/lower jaw of a patient. This method includes constructing a real/concrete negative impression of the patient's jaw; producing a first digital image of the real/concrete negative impression; producing a second digital image of the real/concrete negative impression installed in the patient's jaw; using the first digital image in order to reconstruct the outline of the second digital image distorted by the artifacts, so as to obtain a computer representation, free of the artifacts, of the negative impression of the patient's jaw.
The corrected digital image is then manipulated on the computer so as to add the guide bores of the plant and obtain a virtual template and, via a modeling process with a rapid prototyping machine, lastly generating the real surgical template.
Document WO2008/045965 describes a method for realising surgical templates for guiding drills during the steps of inserting a dental plant, comprising use of a virtual model of the upper/lower jaw of the patient.
Document FR2916958 illustrates a manufacturing process of a template for fixing a dental plant. Aim of the Invention
In this field, the Applicant has observed that the methods of the above-described type, though guaranteeing an excellent qualitative result, are very expensive for the dentist and therefore also for the patient and at times are not actuable.
It is in fact necessary for the dental surgery to acquire the expensive and complex software for virtual planning and the dentist must be adequately trained to use it. Further, the concrete realization of the surgical template presupposes the use of expensive prototyping and/or milling machines which dental surgeries do not usually possess; for this reason the virtual design has to be sent to specialized centres (outsourcing) which produce the template and send it to the surgery where it is used to carry out the surgical operation. It follows that the times that elapse between the first visit of the patient and the actual operation can be considerably lengthened.
Consequently, the above-described methods have a limited use due to problems of time, costs and logistics (in particular in the emerging markets where there are problems at customs and significant dispatch costs) and due to difficulties connected to the use of information technology instruments and procedures.
The Applicant has therefore recognised the need to provide a method and a kit for making surgical templates for dental implantation which are economical, simple to actuate/use and which enable concretely constructing the template directly by the dentist or the technicians present in the surgery, without the need to use external manufacturing centres. The templates obtained will obviously have to guarantee excellent precision in locating the implantation in the patient's mouth during the surgical operation.
Summary of the Invention
The Applicant has found that the above- listed aims can be attained by a method and a kit as described in the following and according to the appended claims.
In more detail, the invention relates to a method for making surgical templates for dental implantations, comprising:
i. preparing a real model of at least a portion of the upper/lower jaw of a patient; ii. placing in an implant site of said real model at least one real reference pin having one real reference radiopaque portion mounted removably on an end of the real reference pin and emerging from said implant site;
iii. forming on said real model a real radiological template encompassing at least part of said radiopaque reference portion;
iv. removing the real radiological template and the radiopaque reference portion integral with said real radiological template from the real model and from the real reference pin and insert it in the mouth of the patient;
v. subjecting the patient with the real radiological template and the radiopaque reference portion to tomography and acquiring the virtual model of said portion of the upper/lower jaw of the patient and of the radiopaque reference portion;
vi. generating, in the virtual model, a virtual reference pin corresponding to the position of the virtual radiopaque reference portion;
vii. verifying the correct position of the virtual reference pin in the bone of the virtual model of said portion of the upper/lower jaw of the patient;
vii(a). correcting the position of the virtual pin in the virtual model, if differs from a correct position;
viii. installing, on the real reference pin, at least one support element for a guide sleeve;
ix. installing the guide sleeve on the support element and forming, on the real model, a real surgical template provided with the guide sleeve.
In the present description and appended claims, the adjective "real" is taken to mean a concrete and material object. The adjective "virtual" is understood to mean an electronic object reproduced on a computer.
The real model of the portion of the upper/lower jaw of a patient reproduces the existing dentition and the tissues and is preferably a plaster cast obtained using known techniques (a model of the impression taken from the patient) or a model originating from an intra-oral scan realized using rapid prototyping or milling techniques.
The implantation site is a zone in the real model (and the portion of the upper/lower jaw of the patient) in which an implant is to be inserted on which a dental prosthesis will be fixed.
Preferably, the real reference pin is made of metal. Preferably, the radiopaque reference portion is made of plastic and is mounted preferably removably on an end of the real reference pin.
The real radiological template is preferably manually constructed with resin.
More preferably, to construct the radiological template the resin is first applied on the real model, such as to partially sink the radiopaque reference portion, and then a bite is applied on the resin to gauge the occlusion. The bite, the consolidated resin and the radiopaque reference portion, which form the radiological template, are then inserted into the patient's mouth.
The vertical model acquired by means of tomography (CT) comprises the virtual model of the bone structure of the upper/lower jaw of the patient and the virtual model of the radiopaque reference portion.
The virtual reference pin is generate by means of a software program in the virtual model acquired by means of tomography and the position of the virtual reference pin in the virtual model is identified by the position of the virtual radiopaque reference portion. The virtual reference pin preferably reproduces the structure of the real plant (which typically exhibits a profile of a threaded pin) which will have to be inserted in the patient's bone. The relative position of the virtual reference pin with respect to the virtual radiopaque reference portion in the virtual model is the same relative position of the real reference pin with respect to the radiopaque reference portion in the real plaster model.
In the virtual model, as the bone structure is visible, it is possible to verify, even if only visually on the monitor, if the virtual reference pin is located correctly therein or it is too close to the limit of the bone or even exceeds it.
Thus it will be possible to correctly position the guide sleeve for the miller on the real reference pin of the plaster model and then construct on it the real surgical guide. The surgical template is preferably constructed manually with photo- polymerisable resin in such a way that it embeds the guide sleeve.
To this end, if the virtual position is correct, after step vii. and before step viii., the position of the virtual reference pin in the virtual model is kept unchanged and the support element is selected such as to maintain the guide sleeve aligned to the real reference pin. In other words, if the virtual position is already correct, this means that the dentist has inserted the real reference pin thus enables (once the guide sleeve becomes part of the surgical template which is formed about it) drilling a hole in the correct position in the patient corresponding to the position of the real reference pin in the plaster model.
If the position is not correct, after step vii. and before step viii., the position of the virtual reference pin in the virtual model is adjusted and the support element is selected so as to vary the position of the guide sleeve with respect to the real reference pin according to the correction of the position of the virtual reference pin. In other words, if the virtual position is wrong it means that the dentist has inserted the real reference pin in the real model with a positioning error. The positioning is corrected in the virtual model. The selected support element is installed on the end of the real reference pin, in place of the radiopaque reference portion, displaces the guide sleeve (translation and rotation) from the original position, in which it would have produced a hole in the position (wrong) corresponding to the position of the real reference pin in the real model, to the new virtually-identified position, in which it produces a hole in the position (correct) corresponding to the position of the correct virtual reference pin in the virtual model.
The virtual reference pin in the virtual model is preferably displaced into the occlusal plane and the support element exhibits at least a varying element of the occlusal position corresponding to the displacement of the virtual reference pin. The virtual reference pin in the virtual model is preferably rotated and the support element exhibits at least a varying element of the angular position corresponding to the rotation of the virtual reference pin.
The virtual reference pin in the virtual model is preferably translated along the longitudinal axis thereof and a spacer is selected for regulating the depth of the milling on the patient corresponding to the translation of the virtual reference pin. In the case that the positioning error is relative to the depth of the pin, the correction is not made by means of an appropriate support element for the guide sleeve but by correcting the depth of the milling by means of a spacer to be installed on the miller itself when working on the patient. Alternatively, although not described in detail, this correct might, like the others, be obtained by means of an appropriate shape/dimension of the support element.
In a different aspect, the invention relates to a kit for making surgical plates for dental implantation according to the above-described method, comprising:
at least one real reference pin having one radiopaque reference portion; a support element for guide sleeves capable of being installed on the real reference pin instead of the radiopaque reference portion.
The support element preferably comprises an element for changing the occlusal position and/or an element for changing the angular position.
The support elements are preferably of the single-use type.
The element for changing the occlusal position preferably comprises a body exhibiting a cam seat and installable offset on an end of the real reference pin. The element for changing the occlusal position preferably comprises a cylindrical body installable on an end of the real reference pin with a longitudinal axis thereof inclined with respect to the longitudinal axis of the real reference pin.
Various types of elements for varying the occlusal position are preferably available, as well as various types of elements for varying the angular position, inter-combinable to form the appropriate support element.
The pin, the element for varying the occlusal position and the element for varying the angular position are joined by gluing.
In a preferred alternative embodiment, the pin, the element for varying the occlusal position and the element for varying the angular position are joined by jointing, preferably with a snap-fit. This guarantees greater cleanliness and hygiene with respect to the glued solution.
Further, and preferably, once jointed the elements cannot be separated thereafter except by breaking. This characteristic makes them of the single-use type and is a guarantee of precision in assembly thanks to the continual use of new components.
The choice of the elements and the spacer for the miller is preferably done automatically by a software program, on the basis of the virtual correction of the position of the virtual reference pin in the virtual model, and is recommended to the user. To facilitate the identification of the elements for varying, the elements are distinguished by different colouring. The coupling of the elements for varying is preferably done by jointing.
The kit (pins, elements for varying the occlusal and angular position, spacers) is preferably sold as a complete kit together with the software, resin/s, silicone for the bit, milling bits.
In a variant embodiment, the kit does not comprise the elements for varying the occlusal and angular position, combinable with one another, but the software, starting again from the displacement of the virtual pin, is able to virtually generate the suitable and customised support element (or the single elements for varying the position). The 3D file of the support element is sent to a specialized centre where from the virtual support element, and via a rapid prototyping or milling, the real support element is realized and sent to the dental surgery.
The Applicant has found that the method and kit of the invention enable newly reducing costs and also reducing production times for the surgical templates, in particular for rehabilitating partially edentate dental arches. Brief description of the Invention
Further characteristics and advantages will more fully emerge from the detailed description of a preferred but not exclusive embodiment of a method and a kit for making surgical templates for dental implantation according to the present invention.
The detailed description of this embodiment will be made in the following with reference to the accompanying figures, provided by way of non-limiting example, in which:
figures from 1 a to 3a schematically illustrate a front view of a real model of a portion of an upper/lower jaw in a sequence of steps according to the method of the invention;
figures from 1 b to 3b schematically illustrate a lateral view of the same real model of the first sequence of figures 1 a to 3a;
figures 4a and 4b schematically illustrate, respectively in a front view and a lateral view, a radiological guide obtained with the method of the invention;
figures 5a and 6a schematically illustrate a front view of a virtual model of a portion of an upper/lower jaw in a sequence of steps according to the method of the invention;
figures 5b and 6b schematically illustrate a lateral view of the same virtual model in the same sequence as in figures 5a and 6a;
figures from 7 to 10 schematically illustrate the lateral view of figures 5b and 6b in a further sequence of steps according to the method of the invention;
figures from 1 1 to 13 schematically illustrate the lateral view of the real model of figures from 1 b to 3b in a further sequence of steps according to the method of the invention; figure 14 is a front view of the real model on which the surgical template of the method of the invention has been made;
figure 15 illustrates a first element of the kit according to the invention;
figure 16 illustrates a set of second elements of the kit of the invention;
figure 17 illustrates a third element of the kit of the invention;
figure 18 illustrates the second and third element of figures 16 and 17, associated to form a support element arranged on the first element;
figure 19 illustrates a fourth element of the kit associated to the support element of figure 18;
figure 20 illustrates a fifth element of the kit of the invention;
figures from 21 to 25 illustrates a different embodiment of the elements of figures from 15 to 19.
Detailed Description of the Preferred Embodiments of the Invention
With reference to the attached figures and in accordance with a preferred but non- limiting embodiment, the kit of the invention comprises a plurality of real reference pins 1 made of metal. Each of the pins 1 (figures 15 and 21 ) exhibits a first portion 1 a intended to be inserted in a real model of a portion of the upper/lower jaw of a patient and an end portion 1 b designed to protrude from the cast.
In the embodiment illustrated in figure 15, the end portion 1 b exhibits a polygonal section, preferably square.
In the embodiment of figure 21 , the end portion 1 b is circular and includes a pair of hooks 14 that protrude from an end surface of the end portion 1 b thereof.
The kit comprises a plurality of radiopaque reference portions 2 (one of which is illustrated in detail in figure 20) made of plastic material, each provided with an engaging seat with the end 1 b of the pin 1 and suitably shaped to securely grip with a resin material in which it is destined to be partially incorporated and to be precisely detected by means of tomography.
The kit includes various types of an element for varying an occlusal position 3 (three of which are illustrated in figure 16 and figure 22), which comprises a body affording a seat 3a installable on an end 1 b of the real reference pin 1 in place of the radiopaque reference portion 2, according to the method described in the following. In the illustrated embodiments, this body is a disc provided with a through-hole which defines the seat 3a. The various types are distinguished by a different position of the seat 3a, more or less centred on the disc. In the embodiment of figure 16, the disc also exhibits a plurality of peripheral recesses 3b.
In the preferred embodiment of figure 22, the disc has three hooks 15 that protrude from an upper surface of the disc itself and an edge in relief 16 inside the seat 3a (only visible in figure 24) is intended to serve as a foothold for the hooks 14 of the end portion 1 b of the pin 1 .
The kit includes various types of an element for varying the angular position 4 (only one shown in figure 17 and, in an alternative embodiment, in figure 23).
In the embodiment of figure 17, the element for varying the angular position 4 comprises a cylindrical body provided with a base 4a from which positioning pins 4b extend. The cylindrical body is positionable on the end 1 b of the real reference pin 1 with the base 4a thereof resting against the disc of the element for varying the occlusal position 3 and each of the pins 4b housed in one of the peripheral recesses 3b (figure 18). The various types are characterized by a different inclination of the axis of symmetry "X-X" of the cylindrical wall 4c with respect to the base 4a which corresponds to a different angle formed between the axis of symmetry "X-X" of the cylindrical wall 4c and a longitudinal axis Ύ-Υ" of the real reference pin 1 (figure 18). In the embodiment of figure 17, the element for varying the angular position 4 can be mounted on the element for varying the occlusal position 3 in various angular positions, rotated about the longitudinal axis Ύ-Υ" of the pin 1 , or an axis parallel thereto, simply by changing the peripheral recesses 3b in which the pins 4b are housed.
In the variant shown in figure 23, the cylindrical body is not provided with the positioning pins 4b but affords a star-shaped hole 17 in the base 4a and an internal edge 18 intended to serve as an entry for the hooks 15 of the element for varying the occlusal position 3 (better viewed in figure 24). In this embodiment too, the element for varying the angular position 4 can be mounted on the element for varying the occlusal position 3 in various angular positions, rotated about the longitudinal axis Ύ-Υ" of the pin 1 or an axis parallel thereto, simply by passing the hooks 15 through different arms of the star-shaped opening 17.
Further, a plug 19 advantageously closes the upper opening of the cylindrical body of the element for varying the angular position 4. The cap 19 can include a color- code for easy identification of the correct angle of the installed element for varying the angular position 4. The kit comprises a plurality of metal guide sleeves 5, each fittable around the cylindrical wall 4c (as shown in figure 19 and, in a variant, in figure 25).
According to the preferred embodiment described, the kit also includes materials for manual realisation of surgical and radiographic templates, such as resin and silicone bites, milling bits and spacers for changing and regulating the milling depth.
In a preferred embodiment of the method of the invention, a mould is made of the patient's mouth and a real model 6, made of plaster, is then made of the interested portion, which cast therefore reproduces existing teeth 6a and the gingival tissue 6b (schematically illustrated in figures 1 a , 2a, 3a, 1 b, 2b, 3b).
In accordance with a variant of the method, an intra-oral scan is performed on the mouth and a model made using RP techniques or milling.
Acting on personal judgement, the dentist inserts one of the pins 1 (figures 1 a and 1 b) in the zone where the implant is to be made for the prosthesis (which in the attached figures consists of only one tooth), taking care to leave the end 1 b protruding from the real model 6. Since the real model reproduces the visible part of the mouth, the dentist cannot know if the pin 1 is positioned correctly in the bone.
The dentist applies one of the portions of radiopaque reference 2 (figures 2a and 2b) on the end 1 b of the real reference pin 1 and then applies the resin 7 (e.g. transparent white) on the real model 6, partially incorporating the radiopaque reference portion 2 (figures 3a and 3b). A bite made of polymer material is then applied on the resin (not illustrated).
The bite (not illustrated) and the polymerized resin 7 form, together with the radiopaque reference portion 2, a radiological template 8 (figures 4a and 4b) which is separated from the real model 6 (in which the real reference pin 1 remains, no longer having the radiopaque reference portion 2) and inserted into the patient's mouth.
The patient with the radiological template 8 is subjected to CT tomography scan and a 3D virtual (virtual model 9) is generated of the bone structure 10' of the portion of the upper/lower jaw interested by the implantation and the radiopaque reference portion 2' (figures 5a and 5b). This virtual model 9 differs from the real model 6 in that in teeth 6a' and bone 10' are represented in it, but not the soft tissue (gums).
The virtual model 9 is manipulated using software and the software is also used to generate and position a virtual reference pin 1 ', which reproduces the geometry of the real plant that will be inserted in the patient's model and which will serve to support the prosthesis (in figures 6a and 6b it is schematically represented). The virtual reference pin V is positioned, with respect to the virtual radiopaque reference portion 2', in the same relative position between the real reference pin 1 and the real radiopaque reference portion 2.
By observing the video display, the dentist is now in a position to verify, on the virtual model 9, whether the position of the virtual reference pin 1 ' in the virtual bone 10' is correct or not.
Figure 7 illustrates an incorrect position; in fact the virtual reference pin 1 ' exits from the bone 10' and is too inclined.
Using the software program, the dentist corrects the position of the virtual reference pin 1 ' in the virtual bone 10' until it is in the correct position. In the illustrated example, the virtual reference pin 1 ' is first shifted towards the right (figure 8) then rotated until it is substantially perpendicular to the occlusal plane (figure 9); then it is translated vertically (figure 10).
These virtual movements are reproduced on the real reference pin 1 inserted in the real model 6 by moving only the terminal end 1 b of the real reference pin 1 b, by application on the terminal end 1 b of the element for varying the occlusal position 3 (figure 1 1 ) and the element for varying the angular position 4 (figure 12) previously described and illustrated in figures 16 and 17 or the ones illustrated in figures 22 and 23.
In the embodiment shown in figures 15-19, the elements of the kit (pin 1 , element for varying the occlusal position 3 and the element for varying the angular position 4) are mutually bonded.
The elements of the embodiment illustrated in figures 21 -25 are advantageously reciprocally jointed and cannot be separated without being broken. In particular, as clearly visible in figure 24, the hooks 14 of the pin 1 inserted in the seat 3a snap- engage with the relief 16 of the element for varying the occlusal position 3. The hooks 15 of the element for varying the occlusal position 3 snap-engage with the internal edge 18 of the element for varying the angular position 4. The guide sleeve 5 which is installed on the element for varying the angular position 4 (figures 13, 19 or 25) is thus able to guide a tip of a milling bit in the direction of the virtual reference pin 1 ', which is corrected with respect to the direction of the real reference pin 1 . The vertical correction or depth correction of the milling is, on the other hand, obtained by using a suitable spacer for the tip of the miller (not illustrated inasmuch of known type).
The choice of the elements for varying the position 3, 4 and the spacer from among those available in the kit is supplied by the software.
More in detail, once the dentist has used the software program to correct the position of the virtual reference pin 1 ', the software, having the performed spatial correction as input, provides as output the correct combination or combinations of the elements for varying 3, 4 and the spacer.
The dentist assembles one of the elements for varying the occlusal position 3 with one of the elements for varying the angular position 4, as suggested by the software, such as to form a support element 1 1 on which the guide sleeve 5 is engaged.
The dentist or dental technician constructs the surgical template 13 with the resin 12 around the guide sleeve 5 and 6 above the real model the surgical guide 13, which template 13 will then be applied in the patient's mouth in order to drill the hole intended to receive the implant in the correct place. The support element 1 1 and the real reference pin 1 remain in the real model as a prosthetic reference for the laboratory.

Claims

1 . Method for making surgical templates for dental implantation, comprising:
1. preparing a real model (6) of at least a portion of the upper/lower jaw of a patient;
ii. placing in an implant site of said real model (6) at least one real reference pin (1 ) having one real reference radiopaque portion (2) removably mounted on an end of the real reference pin (1 ) and emerging from said implant site;
iii. forming on said real model (6) a real radiological template (8) encompassing at least part of said radiopaque reference portion (2);
iv. removing the real radiological template (8) and the radiopaque reference portion (2) integral with said real radiological template (8) from the real model (6) and from the real reference pin (1 ) and insert it in the mouth of the patient;
v. subjecting the patient with the real radiological template (8) and the radiopaque reference portion (2) to tomography and acquiring the virtual model (9) of said portion of the upper/lower jaw of the patient and of the radiopaque reference portion (2');
vi. generating, in the virtual model (9), a virtual reference pin (V) corresponding to the position of the virtual radiopaque reference portion (2');
vii. verifying the correct position of the virtual reference pin (V) in the bone of the virtual model (9) of said portion of the upper/lower jaw of the patient;
vii(a). correcting the position of the virtual pin (V) in the virtual model (9), if differs from a correct position;
viii. installing, on the real reference pin (1 ), at least one support element (1 1 ) for a guide sleeve (5);
ix. installing the guide sleeve (5) on the support element (1 1 ) and forming, on the real model (6), a real surgical template (13) provided with the guide sleeve (5).
2. Method according to claim 1 , wherein, if the position of the virtual reference pin (1 ') matches with the correct position, said position of the virtual reference pin (1 ') in the virtual model (9) is kept unchanged and the support element (1 1 ) keeps the guide sleeve (5) aligned to the real reference pin (1 ).
3. Method according to claim 1 , wherein, if the position of the virtual reference pin (1 ') differs from the correct position, said position of the virtual reference pin (1 ') in the virtual model (9) is adjusted and the support element (1 1 ) changes the position of the guide sleeve (5) with respect to the real reference pin (1 ) according to said adjustment of the position of the virtual reference pin (V).
4. Method according to claim 3, wherein, after step vii. and before step viii., the virtual reference pin (V) in the virtual model (9) is displaced in the occlusal plane and the support element (1 1 ) has at least one element for changing the occlusal position (3) corresponding to said displacement of the virtual reference pin (1 ').
5. Method according to claim 3 or 4, wherein, after step vii. and before step viii., the virtual reference pin (1 ') in the virtual model (9) is rotated and the support element (1 1 ) has at least one element for changing the angular position (4) corresponding to said rotation of the virtual reference pin (1 ').
6. Method according to one of claims from 2 to 5, wherein, after step vii. and before step viii., the virtual reference pin (1 ') in the virtual model (9) is translated along its longitudinal axis (Y-Y) and a spacer is chosen to adjust the milling depth on the patient corresponding to said translation of the virtual reference pin (1 ').
7. Kit for making surgical templates for dental implantation according to the method of one or more of claims 1 to 6, comprising:
at least one real reference pin (1 ) having one 10 radiopaque reference portion (2); a support element (1 1 ) for guide sleeves (5) capable of being installed on the real reference pin (1 ) instead of the radiopaque reference portion.
8. Kit according to claim 7, wherein the support element (1 1 ) comprises an element for changing the occlusal position (3) and/or an element for changing the angular position (4).
9. Kit according to claim 8, wherein the element for changing the occlusal position
(3) comprises a body having an eccentric seat (3a) and capable of being installed eccentrically on one end of the real reference pin (1 ).
10. Kit according to claim 8, wherein the element for changing the angular position
(4) comprises a cylindrical body capable of being installed on one end of the real reference pin (1 ) with its longitudinal axis (X-X) inclined with respect to the longitudinal axis (YY) of the real reference pin (1 ).
PCT/IB2013/054779 2012-06-12 2013-06-11 Method and kit for making surgical templates for dental implantation WO2013186702A1 (en)

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IT001012A ITMI20121012A1 (en) 2012-06-12 2012-06-12 METHOD AND KIT FOR THE REALIZATION OF SURGICAL TEMPLES FOR DENTAL IMPLANTOLOGY
ITMI2012A001012 2012-06-12

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WO2016172133A1 (en) * 2015-04-20 2016-10-27 Provisional Implant Technology, Llc Method of making a radiographic guide and a surgical stent /guide for dental implants
WO2019151923A1 (en) * 2018-01-31 2019-08-08 Soederstroem Staffan Method for manufacture of a jaw customized guide, system for aiding mounting of tooth implants, jaw customized guide, a radiopaque marker element and software for determining data for manufacture of a jaw customized guide for guiding mounting of permanent tooth implants

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FR2916958A1 (en) 2007-06-11 2008-12-12 Frederic Bousquet METHOD FOR MANUFACTURING DRILLING JIG FOR INSTALLATION OF DENTAL IMPLANT, AND TUTOR DEVICE FOR IMPLEMENTING IT

Patent Citations (3)

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WO2003060825A2 (en) 2002-01-16 2003-07-24 Andrei Feldman Oral implant template
WO2008045965A2 (en) 2006-10-10 2008-04-17 Stumpel Lambert J Surgical guide for dental implant and methods therefor
FR2916958A1 (en) 2007-06-11 2008-12-12 Frederic Bousquet METHOD FOR MANUFACTURING DRILLING JIG FOR INSTALLATION OF DENTAL IMPLANT, AND TUTOR DEVICE FOR IMPLEMENTING IT

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016172133A1 (en) * 2015-04-20 2016-10-27 Provisional Implant Technology, Llc Method of making a radiographic guide and a surgical stent /guide for dental implants
US9770218B2 (en) 2015-04-20 2017-09-26 Provisional Implant Technology, Llc Method of making a radiographic guide and a surgical stent/guide for dental implants
WO2019151923A1 (en) * 2018-01-31 2019-08-08 Soederstroem Staffan Method for manufacture of a jaw customized guide, system for aiding mounting of tooth implants, jaw customized guide, a radiopaque marker element and software for determining data for manufacture of a jaw customized guide for guiding mounting of permanent tooth implants
EP3745996A4 (en) * 2018-01-31 2022-01-05 Söderström, Staffan Method for manufacture of a jaw customized guide, system for aiding mounting of tooth implants, jaw customized guide, a radiopaque marker element and software for determining data for manufacture of a jaw customized guide for guiding mounting of permanent tooth implants

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