RU2600867C1 - Method for local immune correction in dental implantation combined with closed sinus lifting - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to surgical dentistry, and can be used for local immune correction during the dental implantation combined with closed sinus lifting. Betaleukin immunomodulator is applied locally, solution of which is used to irrigate the implant bone bed near the maxillary sinus mucosa by a sterile syringe with blunted needle before installation of the implant. “Coletex-Beta” gel is used to react on the installed implant area locally.

EFFECT: invention promotes reduction of dental implantation complications with closed sinus lifting, exclusion of the implant in case of perforated maxillary sinus mucosa due to stimulation of anti-inflammatory and repair processes by recombinant interleukin-1β, which improves functional results of treatment.

1 cl, 8 dwg, 3 tbl

Description

The invention relates to medicine, in particular to dentistry and immunology, and can be used when performing dental implantation with a simultaneous closed sinus lift.

Currently, in the treatment of patients with adentia, dental implants are widely used as supports for orthopedic design. Many years of experience in the surgical stage of restoration of the dentition using dental implantation revealed the most difficult clinical conditions under which the prerequisites for the development of complications in the early postoperative period are created. Most often it is a tooth extraction with simultaneous implantation; implantation in the distal parts of the lower jaw and implantation with simultaneous sinus lift [Nechaeva N.K. Complications of dental implantation // Military Medical Journal. - 2009. - No. 3. - S. 39-40].

To date, in clinical practice, apply the sinus lift options:

1) Closed - internal or indirect "sinus lift".

2) External or direct "sinus lift" with open access through the lateral bone window [M. Liang, 2008].

A closed sinus lift is used with a residual bone height of 7-8 mm, and this technique allows you to get bone growth in the distal upper jaw, sufficient to install the implant [Yaremenko AI, Vinogradov S.Yu. The operation of raising the bottom of the maxillary sinus with its chronic inflammation // Institute of Dentistry. - 2008. - No. 1. - S. 68-70].

The disadvantage of this technique are: the lack of visual control during the stage of raising the mucous membrane of the maxillary sinus; fairly frequent perforations of the Schneider membrane with the formation of an anastomosis between the sinus and oral cavity and subsequent inflammatory processes in the region of the upper jaw and maxillary sinus; difficulties in correlating the extent of exfoliation of the sinus mucosa with its thickness and ability to deform. Due to the above complications, implant disintegration is possible in the early postoperative period.

There are a number of ways that mitigate the risks of perforation of the sinus mucosa and related complications:

1. OSFE - Osteotome Sinus Lift Elevation [Khabiev K.H. The use of ostetomes for closed sinus lift / K.N. Khabiev // Dental implantology and surgery. - No. 1 (14). - 2014. - S. 41];

2. BASS - Ballon-assistierte Sinusbodenschleimhautelevation. Mucous sinus lift using a hydropneumatic balloon to exfoliate the maxillary sinus mucosa, which is inserted into the bottom of the bone bed and filled with saline [Chho Yong-seok. The use of CAS - KIT in clinical cases // Dental implantology and surgery. - No. 1 (14). - 2014. - S. 74-75];

3. The technique of using ultrasonic instruments with diamond coatings, which are known to be safer for soft tissues. The risk of perforation of the maxillary sinus membrane is low 6% compared to 14-56% when performing sinus lift using rotating tools [M. Petrutstsi, R. Chechcharelli, T. Testori, F.R. Grassy. Hydropneumatic sinus lift method: a retrospective study involving 40 patients // Periodontology and restoration dentistry. - PRD 2013. - S. 47-53].

However, these techniques require additional equipment of the clinic and specialist training.

Currently, there is no literature data that provides a clear description and recommendations on the tactics of a dentist-surgeon in case of perforation of the maxillary sinus mucosa at the time of the closed sinus lift and the methods of its medical support, the purpose of which is to reduce possible inflammatory complications. One of the most promising areas in the development of dentistry is the search for adequate immunocorrection, including recombinant cytokines, and the search for drugs that increase the effectiveness of traditional methods of treatment [Safonova TA, Butyugin II, Dolgushin II // Bulletin of new medical technologies. - No. 3 (T. XVI). - 2009. - S. 134-135]. Nevertheless, there is only a few data on the use of cytokine therapy in the clinic of surgical dentistry as a medical support for dental implantation. In particular, the positive effect of the local use of recombinant interleukin-2 (roncoleukin) in surgical dentistry during dental implantation has been determined [Patent RU 2429796, IPC A61C 8/00, A61M 1/38, A61K 38/20, A61P 41/00, 29.03. 2010, Solomin V.N., Vavin V.V., Tolchenitsin I.A., Makhov V.A.].

Betaleikin ® is a drug based on recombinant human interleukin-1β (IL-1β), a complete analogue of the human protein IL-1β, created by genetic engineering. The drug is being actively introduced into clinical practice, including as a means for local immunotherapy. In particular, there are methods for the local use of betaleukin in ophthalmology, otorhinolaryngology, ophthalmology, and dentistry:

1. Local immunotherapy after tympanoplasty (Patent RU 2355416, IPC A61K 38/20, A61P 27/16, A61F 11/00, 06/20/2007, Medvedsky M.A. et al.) In the form of ear drops at a concentration of 5 ng / ml each 2-3 drops in the ear canal. The method provides a reduction in the period of engraftment of a non-asymptomatic flap.

2. As a tool for the treatment of chronic purulent rhinosinusitis (Patent RU 2178676, MKP A61B 17/24, Aznabaeva L.F. and others), betaleikin is injected into the focus of inflammation at a concentration of 20 ng / ml in a volume of 5 ml to increase the effectiveness of the treatment of the disease .

3. For local immunocorrection of purulent wounds of the maxillofacial region (Patent RU 2361626, IPC A61M 35/00, A61K 38/21, A61P 37/02, A61P 17/02, 06/04/2007, Latyushina LS, etc.) .

4. In ophthalmology in the treatment of sluggish tuberculous uveitis. To do this, against the background of anti-tuberculosis therapy, betaleykin is additionally administered parabulbarly, which ensures increased treatment efficiency due to local immunostimulating action (Patent RU 228313, IPC A61K 38/20, A61P 31/06, Hokkanen V.M., Solovieva M.V., Ionova O.G.).

5. In the treatment of patients with inflammatory periodontal diseases - the inclusion of the drug in the treatment complex helps to eliminate most of the symptoms of the disease, the intensity of the inflammatory process in the periodontal tissues decreases [Safonova TA, Butyugin II, Dolgushin II The use of the betaleukin immunomodulator in the complex treatment of inflammatory periodontal diseases // Bulletin of new medical technologies - No. 3 (T. XVI). - 2009. - S. 134-135].

However, there are no works on the use of betaleikin during dental implantation and related surgical interventions (closed sinus lift, open sinus lift, bone grafting). This method of local use of the drug betaleikin in various areas of medicine, namely in ophthalmology, otorhinolaryngology and dentistry, is taken as a prototype.

The basis of the invention is the task of preserving and fully integrating the implant during manipulation of the closed sinus lift in case of close contact of the implant surface with the maxillary sinus mucosa or perforation of the maxillary sinus mucosa.

This problem is solved by the fact that in the method of closed sinus lift, the immunomodulating drug betaleukin (recombinant IL-1β) is locally used.

A comparable analysis of the claimed and known technical solutions showed that the proposed method meets the criterion of "novelty."

The inventive method is as follows.

For the purpose of local immunocorrection, intraoperatively and within 10 days of the postoperative period, the following is used: a solution of the betaleikin preparation (registration certificate No. PN 000222/01 of 12/20/2007, manufacturer of FSUE GNII Especially Pure Biological Products, St. Petersburg, Russia); hydrogel material “Coletex-Beta” with sodium alginate, dimexide and interleukin-1 beta (TU 9393-018-58223785-2011, manufacturer LLC “Coletex”. Moscow, Russia). During the operation, the patient is in a horizontal position. After infiltration anesthesia, a mucosal incision is made in the middle of the alveolar ridge or with a slight displacement to the palatine side. The mucosal-periosteal flap is exfoliated, while the alveolar bone is exposed. A bone bed is formed for the implant in accordance with the rules for preparing the bone and the direction of the implant installation reference. The maxillary sinus does not reach 1-2 mm. Through a bone bed formed by an osteotome of the corresponding diameter, “breaking” of the bone wall of the maxillary sinus bottom is performed according to the “green twig” type. The prepared betaleikin solution in an amount of 1.0 ml (the concentration of the main substance is 0.5 μg in 1.0 ml, dilution in 1.0 ml of sterile physiological saline) with a sterile syringe with a blunt needle, irrigate the bone bed near the contact with the mucosa of the maxillary sinus and immediately establish implant in the correct orthopedic position. The implant is closed with a plug, the mucoperiosteal flap is sutured tightly with interrupted sutures. Over the next 10-12 days (before removing the sutures), the Coletex-Beta gel is applied 1-2 times a day to the area of the alveolar process of the upper jaw twice a day, the exposure time is 15-20 minutes.

The inventive method avoids the inflammatory complications of dental implantation with closed sinus lift, including implant rejection in the case of perforation of the mucous membrane of the maxillary sinus due to the stimulation of recombinant interleukin-1β anti-inflammatory and reparative processes, including processes of osteogenesis.

In order to justify the proposed method, a comprehensive treatment was performed for 30 people aged 30 to 64 years (17 women, 13 men) who applied to the clinic to restore the absence of teeth using dental implantation. Criteria for inclusion in the study: 1) the presence of an included and end defect of dental gums in the upper jaw; 2) age from 25 to 70 years; 3) informed voluntary consent of the patient to participate in the study. Exclusion criteria: 1) inflammatory diseases and proliferative processes of the maxillary sinus; 2) hormonal disorders; 3) oncological diseases; 4) autoimmune diseases; 5) pregnancy, lactation; 6) the patient refuses to participate in the examination.

Patients included in the study by randomization of sequential numbers were divided into two groups: 1) a comparison group (n = 15), whose patients underwent dental implantation in the upper jaw with closed sinus lift, without medication with immunotropic drugs; 2) the main group (n = 15), where local immunocorrection with betaleukin was used according to the above method. Patients underwent installation of root implants "Implantium" manufactured in South Korea.

In the course of the study, a number of clinical signs were studied in all patients, which made it possible to evaluate the dynamics of the postoperative course of the process of implant integration and the general condition of patients — the time (in days) of the disappearance of soft tissue edema on the face, the disappearance of marginal hyperemia and mucosal edema in the peri-implant zone, and the presence of changes from the side maxillary sinus. Postoperative follow-up was performed on the 3rd, 6th, 12th and 28th days.

X-ray examination of patients was carried out, the results of orthopathography were analyzed (ORTHOPHOS XG DS / Ceph - Germany) (the study was conducted before surgery and in dynamics); dental computed tomography (three-dimensional dental tomograph "GALILEOS" from Sirona (Germany) (the study was carried out before surgery, after opening the implant and manipulating the installation of the healing abutment).

The device "Periotest" (PERIOTEST S firm Siemens - Germany) recorded the stability of the implant at the time of installation and disclosure of the latter.

As a result of the study, it was determined that in the group of patients receiving immunotherapy, relief of signs of inflammation in the area of surgical intervention was recorded at an earlier date (table 1). Purulent-inflammatory complications (osteomyelitis of the upper jaw, odontogenic maxillary sinusitis) and rejection of established implants in patients who were treated with betaleukin were not detected. Adverse reactions are also not registered. At the same time, in the comparison group, the 1st patient (7%) in the postoperative period developed inflammatory complications in the form of limited osteomyelitis of the upper jaw and after three to four weeks the implant was rejected. On the fifth day after surgery, two patients (14%) developed symptoms of acute odontogenic sinusitis of the maxillary sinus. Three patients showed persistence of edema of the oral mucosa in the peri-implant zone for more than six days.

Analysis of the results of computed tomography in patients included in the study revealed a statistically significant increase in bone volume in patients locally receiving betaleukin by the third month of observation (table 2).

In terms of the periotest, we studied the objective stability of the implant to confirm its integration at the time of disclosure and revealed differences - in the group of patients receiving immunotherapy, at the time of implant opening, a more pronounced degree of osseointegration was recorded (table 3).

The proposed method is confirmed by the following clinical examples.

Example No. 1

Patient X., 34 years old, came to the clinic on 02.16.2014 with a complaint about the absence of the first molar in the upper jaw on the left and discomfort when eating. From the medical history: tooth 26 was removed about two years ago due to complications after endodontic treatment.

Conducted a comprehensive survey. A clinical examination of the missing tooth 26 revealed a slight atrophy of the alveolar ridge in height and width, which does not require bone grafting. From the side of the mucous membrane of the oral cavity and the attached gums, no pronounced changes were found. The adjacent teeth are 25 and 27 intact. On computed tomography, there was no pathology from the maxillary sinus, the bone height from the alveolar ridge to the maxillary sinus border was 7-8 mm at different points of application.

The planned operation was performed: closed sinus lift with simultaneous placement of the dental implant in the position of the missing tooth 26, during which the betaleukin preparation was applied locally. Healing took place without complications. The patient underwent dressings with Coletex-Beta. The disappearance of local signs of inflammation was recorded on average at 4-6 days.

Four months later, the gum shaper was installed, and a month later the orthopedic design was fixed.

A computed tomogram of the patient is presented for comparing bone density indices, which was made after implant placement (Fig. 1, 3) and four months later at the moment of opening of the latter and fixation of the gingiva former (Fig. 2, 4).

Example No. 2

Patient K., 44 years old, came to the clinic 03.03.2014 with a complaint about the absence of the first molar, the first premolar on the upper jaw on the right and the discomfort when eating. From the medical history: tooth 16 and 14 were removed a year ago due to complications after endodontic treatment.

Conducted a comprehensive survey. A clinical examination in the area of missing teeth 16 and 14 atrophy of the alveolar ridge was not detected. The bone width was sufficient to place the implants in the correct orthopedic position without additional bone plastic. From the side of the mucous membrane of the oral cavity and the attached gums, no pronounced changes were found. The adjacent teeth are 17 and 15 vital. There was no pathology from the maxillary sinus on computed tomography, the bone height from the alveolar ridge to the maxillary sinus border to the levels of the missing tooth 16 was 6-7 mm at different points of application.

The planned operation was performed: closed sinus lift with simultaneous placement of the dental implant in the position of the missing tooth 16, during which the betaleukin was applied locally. At the time of breaking, an unplanned punctate puncturing of the mucous membrane of the maxillary sinus occurred, which was confirmed by a nasal test. The rupture of the mucous membrane occurred due to the displaced bone fragment, which was subsequently seen in the x-ray.

According to the scheme of the presented method, a local solution of betaleukin is applied locally. In the postoperative period, dressings were performed with Coletex-Beta gel in the form of local application along the line of sutures to the wound surface of the oral mucosa.

The postoperative period was uneventful. The implant was opened and the gingiva former was installed according to plan four months later.

A computed tomogram of the patient is presented for comparing bone density indices, which was made after implant placement (Fig. 5, 7) and four months later at the moment of opening of the latter and fixation of the gingiva former (Fig. 6, 8).

It was established that local immunocorrection with betaleukin had a significantly higher clinical and immunological efficacy in comparison with traditional local methods of treatment. In the process of researching the patented method, the positive effect of betaleukin on the dynamics of the postoperative course was determined. It should be emphasized that, during the manipulation that occurred during the time, closed sinus lift perforation of the maxillary sinus mucosa was not observed in the postoperative period of implant rejection. It should be noted that in the comparison group of patients with the same situation, inflammatory complications and implant rejection arose.

Thus, the proposed method of local immunocorrection during dental implantation with simultaneous closed sinus lift reduces the risk of complications.

The invention can be used in medicine, in particular in surgical dentistry, to restore lost teeth by the method of dental implantation.

Claims (1)

The method of local immunocorrection during dental implantation with simultaneous closed sinus lift, characterized in that locally use the immunomodulating preparation betaleikin, the solution of which is used to irrigate the implant’s bone bed near the maxillary sinus mucosa with a sterile syringe and a blunt needle before installing the implant and topically install the implant in the form of Coletex-Beta gel, which helps to reduce the complications of dental implantation with closed sinus lift , rejection of the implant in case of perforation of the mucous membrane of the maxillary sinus due to stimulation of recombinant interleukin-1β anti-inflammatory and reparative processes, which improves the functional results of treatment.

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