CN111281809A - Lubricant for root canal therapy and preparation method thereof - Google Patents

Lubricant for root canal therapy and preparation method thereof Download PDF

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Publication number
CN111281809A
CN111281809A CN202010186806.XA CN202010186806A CN111281809A CN 111281809 A CN111281809 A CN 111281809A CN 202010186806 A CN202010186806 A CN 202010186806A CN 111281809 A CN111281809 A CN 111281809A
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lubricant
root canal
stirring
percent
time
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CN111281809B (en
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关晴光
耿丽鑫
邹萍
肖丽娟
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Harbin Quankang Pharmaceutical Co Ltd
Sichuan Sushuang Medical Product Co ltd
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Harbin Quankang Pharmaceutical Co Ltd
Sichuan Sushuang Medical Product Co ltd
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Abstract

The invention relates to a lubricant for root canal treatment and a preparation method thereof, belonging to the technical field of oral care. In order to solve the problems of poor fluidity and unsatisfactory root canal preparation effect of the existing root canal lubricant, the invention provides a lubricant for root canal treatment, which comprises the following components in percentage by mass: 17 to 22 percent of disodium ethylene diamine tetraacetate, 20 to 60 percent of glycerol, 5 to 20 percent of polyethylene glycol-400, 1 to 5 percent of polyoxyl stearate (40), 1 to 1.4 percent of sodium lauryl sulfate and 0.1 to 5 percent of sodium hydroxide. The lubricant for endodontic treatment provided by the present invention is a cream-like paste having high fluidity and high permeability. The paste softens dentin of root canal wall when expanding and forming, has good lubricating effect, is beneficial to expanding and filing and dredging tiny calcified root canal, reduces preparation difficulty of tiny calcified root canal, shortens mechanical preparation time and prevents breakage and loss of instruments.

Description

Lubricant for root canal therapy and preparation method thereof
Technical Field
The invention belongs to the technical field of oral care, and particularly relates to a lubricant for root canal treatment and a preparation method thereof.
Background
Thorough cleaning of the root canal system is a prerequisite for successful root canal treatment. Root canal preparation requires removal of necrotic pulp tissue, microorganisms and infected dentin within the root canal of a tooth. The dentin is removed during the preparation of the root canal, inevitably forming a smear layer, and covering the entire canal wall. The smear layer contains not only a large amount of bacteria but also prevents the disinfectant from entering the root canal system and dentinal tubules, affecting the disinfection effect, and affecting the adhesion between the root canal filling material and the root canal wall, resulting in failure of root canal treatment. Root canal preparation also requires the preparation of root canal morphology to accommodate root canal filling material to seal the apical foramen, and the 1/3 narrow lumen at the apical end, general root canal lubricants have poor flow properties and are not easy to reach the apical part and cannot maintain effective concentration.
Disclosure of Invention
The invention provides a lubricant for root canal treatment and a preparation method thereof, aiming at solving the problems of poor mobility of the existing root canal lubricant and unsatisfactory root canal preparation effect.
The technical scheme of the invention is as follows:
a lubricant for root canal therapy comprises the following components in percentage by mass: 17 to 22 percent of disodium ethylene diamine tetraacetate, 20 to 60 percent of glycerol, 5 to 20 percent of polyethylene glycol-400, 1 to 5 percent of polyoxyl stearate (40), 1 to 1.4 percent of sodium lauryl sulfate and 0.1 to 5 percent of sodium hydroxide.
Further, the composition comprises the following components in percentage by mass: 20% of disodium ethylene diamine tetraacetate, 50% of glycerol, 20% of polyethylene glycol-400, 5% of polyoxyl stearate (40), 1% of sodium lauryl sulfate and 4% of sodium hydroxide.
Further, the pH value of the lubricant is 6-9.
A method for preparing a lubricant for endodontic treatment, comprising the steps of:
adding purified water into a homogenizing emulsification tank, adding sodium hydroxide into the purified water, and stirring for a certain time at a certain rotating speed to form a uniform transparent sodium hydroxide solution with the mass concentration of 0.1-5%;
step two, adding polyoxyl (40) stearate into a homogenizing and emulsifying tank, and stirring for a certain time at a certain rotating speed to form a uniform white paste body;
step three, adding glycerol and polyethylene glycol-400 into a homogenizing emulsifying tank, and stirring for a certain time at a certain rotating speed to form a uniform white paste body;
step four, adding the sodium lauryl sulfate into a homogeneous emulsifying tank, and stirring for a certain time at a certain rotating speed to form a uniform white paste body;
and step five, adding disodium ethylene diamine tetraacetate into a homogenizing emulsifying tank, stirring for a certain time at a certain rotating speed to form a uniform white paste body, homogenizing the obtained paste body, maintaining the emulsifying tank for a certain time under a certain vacuum condition, and filling the obtained paste body into a special dental syringe to obtain the lubricant for root canal therapy.
Further, in the step one, the stirring speed is 30r/min, and the stirring time is 5-30 min.
Further, the stirring speed in the second step is 30r/min, and the stirring time is 5-30 min.
And further, in the third step, the stirring speed is 30r/min, and the stirring time is 5-30 min.
Further, the stirring speed in the fourth step is 30r/min, and the stirring time is 5-30 min.
Further, in the fifth step, the stirring speed is 30r/min, and the stirring time is 60-90 min.
Further, the pressure of the homogenization treatment in the fifth step is 0.05-0.06 mpa, and the homogenization treatment time is 2 min; the vacuum condition of the emulsification tank is-0.08 +/-0.01 MPa, and the maintaining time is 60 min.
The invention has the beneficial effects that:
the lubricant for endodontic treatment provided by the present invention is a cream-like paste having high fluidity and high permeability. This lotion is fine lubrication action when expanding to form, is favorable to expanding file and mediation tiny calcified root canal, reduces the preparation degree of difficulty of tiny calcified root canal, shortens the mechanical preparation time and prevents the rupture and the loss of apparatus.
The disodium ethylene diamine tetraacetate added into the lubricant is a calcium ion chelating agent, can form soluble chelated calcium with calcium ions of hydroxyapatite which is a main component of dentin, has strong decalcification capability on dentin, and can permeate into dentin tubules, collateral root canals and root apex branches, thereby softening the dentin of the root canal wall. Meanwhile, the debris in the mechanical preparation process can be flushed away from the root canal, so that the debris deposition and the blockage of the root canal are avoided. The sodium lauryl sulfate is added into the lubricant, so that the surface tension of the solution can be reduced, and the permeability of the disodium ethylene diamine tetraacetate to dentin can be improved.
According to the invention, the polyoxyl (40) stearate is added to form a specific colloidal polymer which can uniformly wrap the disodium ethylene diamine tetraacetate, and the polyoxyl (40) stearate is used as a matrix and an emulsifier of the cream, so that the decomposition and bioavailability of the medicine are increased, and the cream is more exquisite, white and uniformly emulsified; the polyethylene glycol-400 is a good solubilizer, is stable and is not easy to deteriorate, and can adjust the consistency of the paste and prolong the storage period of the paste; the glycerin is a moisture absorbent, prevents moisture in the paste from escaping, increases the cold resistance of the paste, has stable product properties, is non-toxic and non-corrosive, and is widely used for medicines, foods and cosmetics; the sodium hydroxide is used as a pH regulator, is strong alkali, has low dosage, and has the advantages of no odor, stable pH and no volatilization. The invention keeps the stability of the preparation by the coordination of specific colloid polymer formed by stearic acid polyoxyl (40) ester, ethylene diamine tetraacetic acid, glycerin, polyethylene glycol-400 and sodium lauryl ether sulfate.
The root canal lubricant is opaque cream-like paste, EDTA solid is uniformly coated by the colloidal polymer, the fluidity of the root canal lubricant in the root canal is reduced, and the root canal lubricant is difficult to combine and react with dentin in a solid form. The invention provides the root canal lubricant with fixed proportion and good fluidity through a strict preparation process, can be directly and specially used for the affected part of the root canal through a dental special injection device, is convenient to apply, avoids secondary pollution of the wall tissue of the root canal caused by using mechanical preparation, is directly and specially used for the affected part of the root canal, is convenient to apply, and reduces the workload of medical staff.
Detailed Description
The technical solutions of the present invention are further described below with reference to the following examples, but the present invention is not limited thereto, and any modifications or equivalent substitutions may be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.
Example 1
The present embodiment provides a lubricant for endodontic treatment and a method for preparing the same.
The lubricant for root canal therapy provided by the embodiment comprises the following components in percentage by mass: 20% of disodium ethylene diamine tetraacetate, 50% of glycerol, 20% of polyethylene glycol-400, 5% of polyoxyl stearate (40), 1% of sodium lauryl sulfate and 4% of sodium hydroxide.
The preparation steps of the lubricant for root canal therapy provided by the embodiment are as follows:
adding purified water into a homogenizing emulsification tank, adding sodium hydroxide into the purified water, and stirring for 10min at a speed of 30r/min to form a uniform transparent sodium hydroxide solution with a mass concentration of 4%;
step two, adding polyoxyl (40) stearate into a homogenizing and emulsifying tank, and stirring for 10min at a speed of 30r/min to form uniform white paste;
step three, adding glycerol and polyethylene glycol-400 into a homogenizing and emulsifying tank, and stirring for 20min at the speed of 30r/min to form uniform white paste;
step four, adding the sodium lauryl sulfate into a homogenizing and emulsifying tank, and stirring for 10min at a speed of 30r/min to form uniform white paste;
step five, adding disodium ethylene diamine tetraacetate into a homogenizing emulsifying tank, stirring for 60min at the speed of 30r/min to form a uniform white paste body, homogenizing the obtained paste body under the pressure of 0.05, maintaining the emulsifying tank under the vacuum condition of-0.08 MPa for 60min, and filling the obtained paste body into a special dental syringe to obtain the lubricant for root canal treatment, wherein the pH value of the lubricant is 7.
Example 2
The present embodiment provides a lubricant for endodontic treatment and a method for preparing the same.
The lubricant for root canal therapy provided by the embodiment comprises the following components in percentage by mass: 18% of disodium ethylene diamine tetraacetate, 60% of glycerol, 15% of polyethylene glycol-400, 2% of polyoxyl stearate (40), 1.2% of sodium lauryl sulfate and 3.8% of sodium hydroxide solid.
The preparation steps of the lubricant for root canal therapy provided by the embodiment are as follows:
step one, adding purified water into a homogenizing emulsification tank, adding sodium hydroxide into the purified water, and stirring for 15min at the speed of 30r/min to form a uniform transparent sodium hydroxide solution with the mass concentration of 3.8%;
step two, adding polyoxyl (40) stearate into a homogenizing and emulsifying tank, and stirring for 15min at the speed of 30r/min to form uniform white paste;
step three, adding glycerol and polyethylene glycol-400 into a homogenizing and emulsifying tank, and stirring for 25min at a speed of 30r/min to form uniform white paste;
step four, adding the sodium lauryl sulfate into a homogenizing and emulsifying tank, and stirring for 15min at a speed of 30r/min to form uniform white paste;
and step five, adding disodium ethylene diamine tetraacetate into a homogenizing emulsifying tank, stirring for 70min at the speed of 30r/min to form a uniform white paste, homogenizing the obtained paste under the pressure of 0.06MPa, maintaining the emulsifying tank under the vacuum condition of-0.08 MPa for 60min, and filling the obtained paste into a special dental syringe to obtain the lubricant for root canal treatment, wherein the pH value of the lubricant is 6.
Example 3
The present embodiment provides a lubricant for endodontic treatment and a method for preparing the same.
The lubricant for root canal therapy provided by the embodiment comprises the following components in percentage by mass: 19% of disodium ethylene diamine tetraacetate, 52% of glycerol, 20% of polyethylene glycol-400, 3% of polyoxyl stearate (40), 1.4% of sodium lauryl sulfate and 4.6% of sodium hydroxide solid.
The preparation steps of the lubricant for root canal therapy provided by the embodiment are as follows:
step one, adding purified water into a homogenizing emulsification tank, adding sodium hydroxide into the purified water, and stirring for 20min at a speed of 30r/min to form a uniform 4.6% transparent sodium hydroxide solution;
step two, adding polyoxyl (40) stearate into a homogenizing and emulsifying tank, and stirring for 20min at the speed of 30r/min to form uniform white paste;
step three, adding glycerol and polyethylene glycol-400 into a homogenizing and emulsifying tank, and stirring for 30min at a speed of 30r/min to form uniform white paste;
step four, adding the sodium lauryl sulfate into a homogenizing and emulsifying tank, and stirring for 20min at a speed of 30r/min to form uniform white paste;
and step five, adding disodium ethylene diamine tetraacetate into a homogenizing emulsifying tank, stirring for 80min at the speed of 30r/min to form a uniform white paste, homogenizing the obtained paste under the pressure of 0.05MPa, maintaining the emulsifying tank under the vacuum condition of-0.08 MPa for 60min, and filling the obtained paste into a special dental syringe to obtain the lubricant for root canal treatment, wherein the pH value of the lubricant is 8.
Example 4
The present embodiment provides a lubricant for endodontic treatment and a method for preparing the same.
The lubricant for root canal therapy provided by the embodiment comprises the following components in percentage by mass: 21% of disodium ethylene diamine tetraacetate, 53% of glycerol, 15% of polyethylene glycol-400, 5% of polyoxyl stearate (40), 1.3% of sodium lauryl sulfate and 4.7% of sodium hydroxide solid.
The preparation steps of the lubricant for root canal therapy provided by the embodiment are as follows:
step one, adding purified water into a homogenizing emulsification tank, adding sodium hydroxide into the purified water, and stirring for 30min at a speed of 30r/min to form a uniform transparent sodium hydroxide solution with a mass concentration of 4.7%;
step two, adding polyoxyl (40) stearate into a homogenizing and emulsifying tank, and stirring for 30min at a speed of 30r/min to form uniform white paste;
step three, adding glycerol and polyethylene glycol-400 into a homogenizing and emulsifying tank, and stirring for 20min at the speed of 30r/min to form uniform white paste;
step four, adding the sodium lauryl sulfate into a homogenizing and emulsifying tank, and stirring for 15min at a speed of 30r/min to form uniform white paste;
and step five, adding disodium ethylene diamine tetraacetate into a homogenizing emulsifying tank, stirring for 90min at the speed of 30r/min to form a uniform white paste, homogenizing the obtained paste under the pressure of 0.06MPa, maintaining the emulsifying tank under the vacuum condition of-0.08 MPa for 60min, and filling the obtained paste into a special dental syringe to obtain the lubricant for root canal treatment, wherein the pH value of the lubricant is 9.
A clinical comparative test was conducted with the root canal lubricant provided in example 1 and a commercially available root canal lubricant, the test methods and results were as follows:
test objectives: the method comprises the steps of selecting 96 affected teeth for treatment in 2019 of medical oral departments in 1-6 months, randomly dividing the 96 affected teeth into two groups, adopting the root canal lubricant produced by the company in an experimental group, using the root canal lubricant (6 g/tooth) produced by the Langli biological medicine (Wuhan) company in a control group, observing preparation time, tiny root canal dredging rate and postoperative pain conditions, and evaluating the clinical application effect of the root canal lubricant. 85 patients (45 men and 40 women) needing root canal therapy, 164 root canals of 96 affected teeth (37 anterior teeth, 28 bicuspids and 31 molars), 85 fine root canals of 49 affected teeth in a test group, 47 affected teeth in a control group and 79 fine root canals according to single-double-number random grouping of the treatment sequence of the patients.
Inclusion criteria were: the patient was post molar and diagnosed with pulpitis or periapical periodontitis.
Materials: my company produces root canal lubricants and commercially available root canal lubricants.
The treatment method comprises the following steps: before treatment, an X-ray film of the dental part of the patient is shot, and the length of the root canal and the treatment difficulty are preliminarily estimated. Preparation before root canal preparation is made. Dipping a root canal lubricant into a root canal by using a broach or a primary K file (only the primary file uses the root canal lubricant once), preparing the root canal to the working length by using a balance force method, filling the root canal by using a conventional pressure measurement method, and shooting an X-ray film to evaluate the filling effect. The call is returned within 2 days after the operation, and the doctor is retested after 1 week. Treatment was completed by the same physician, and the time of the procedure was recorded by a nurse, and another physician returned to the patient and recorded to assess pain status. Patients gave informed consent for the conventional course of treatment.
And (3) judging the curative effect:
root canal preparation time: the time from the initial file entering the first root canal orifice to the final file leaving the last root canal, divided by the number of root canal preparations.
Evaluation criteria of postoperative pain degree: level 1: no pain, no self-induced pain and no occlusion pain. And 2, stage: mild pain, subjective pain or mild occlusal pain, without affecting general chewing activity. And 3, level: moderate pain, obvious biting pain, obvious tapping pain but no obvious loosening. 4, level: severe pain, inability of the teeth to touch or loosen, and intolerance of the patient requiring emergency treatment.
The results of the two sets of preparatory time comparisons are shown in table 1:
TABLE 1
Group of Number of samples Preparation time
Experimental group 85 by one (8.23±0.36)min
Control group 79 are provided (15.37±1.22)min
The results of comparing the occurrence of two groups of complications are shown in table 2:
TABLE 2
Group of Number of samples Deviation of root tip Root tip obstruction Step formation Break off of the instrument Pain occurs
Experimental group 85 by one 1 0 0 1 2
Control group 79 are provided 3 1 1 2 4
It can be seen from Table 2 that the incidence of the post-root-canal preparation complications of the experimental group was 4.71%, and the incidence of the post-root-canal preparation complications of the control group was 13.92%.
The experiment shows that the root canal lubricant produced by the invention can effectively remove the dentin staining layer of the root canal, open the mouth of the lateral root canal, maintain the original shape and trend of the root canal, reduce the deviation of the root tip, the blockage of the root tip and the formation of steps, and reduce the wound in the process of treating the root canal, thereby reducing the pain after the root canal is prepared, improving the healing rate of pathological changes of the root tip, simultaneously reducing the labor intensity of doctors, and having simple and convenient operation, safety, time saving, labor saving and low cost.

Claims (10)

1. The lubricant for root canal therapy is characterized by comprising the following components in percentage by mass: 17 to 22 percent of disodium ethylene diamine tetraacetate, 20 to 60 percent of glycerol, 5 to 20 percent of polyethylene glycol-400, 1 to 5 percent of polyoxyl stearate (40), 1 to 1.4 percent of sodium lauryl sulfate and 0.1 to 5 percent of sodium hydroxide.
2. The lubricant for endodontic treatment according to claim 1, comprising the following components in percentage by mass: 20% of disodium ethylene diamine tetraacetate, 50% of glycerol, 20% of polyethylene glycol-400, 5% of polyoxyl stearate (40), 1% of sodium lauryl sulfate and 4% of sodium hydroxide.
3. The lubricant for endodontic treatment according to claim 1 or 2, wherein the lubricant has a pH of 6 to 9.
4. A method for preparing the lubricant for endodontic treatment according to any one of claims 1 to 3, comprising the steps of:
adding purified water into a homogenizing emulsification tank, adding sodium hydroxide into the purified water, and stirring at a certain rotating speed for a certain time to form a uniform 0.1-5% transparent sodium hydroxide solution;
step two, adding polyoxyl (40) stearate into a homogenizing and emulsifying tank, and stirring for a certain time at a certain rotating speed to form a uniform white paste body;
step three, adding glycerol and polyethylene glycol-400 into a homogenizing emulsifying tank, and stirring for a certain time at a certain rotating speed to form a uniform white paste body;
step four, adding the sodium lauryl sulfate into a homogeneous emulsifying tank, and stirring for a certain time at a certain rotating speed to form a uniform white paste body;
and step five, adding disodium ethylene diamine tetraacetate into a homogenizing emulsifying tank, stirring for a certain time at a certain rotating speed to form a uniform white paste body, homogenizing the obtained paste body, maintaining the emulsifying tank for a certain time under a certain vacuum condition, and filling the obtained paste body into a special dental syringe to obtain the lubricant for root canal therapy.
5. The method for preparing the lubricant for endodontic treatment according to claim 4, wherein the stirring rotation speed of step one is 30r/min and the stirring time is 5 to 30 min.
6. The method for preparing the lubricant for endodontic treatment according to claim 5, wherein the stirring rotation speed in the second step is 30r/min and the stirring time is 5 to 30 min.
7. The method for preparing the lubricant for endodontic treatment according to claim 6, wherein the stirring rotation speed in the third step is 30r/min and the stirring time is 5 to 30 min.
8. The method for preparing the lubricant for endodontic treatment according to claim 7, wherein the stirring rotation speed in the fourth step is 30r/min and the stirring time is 5 to 30 min.
9. The method for preparing the lubricant for endodontic treatment according to claim 8, wherein the stirring rotation speed in the fifth step is 30r/min and the stirring time is 60 to 90 min.
10. The method for preparing the lubricant for endodontic treatment according to claim 9, wherein the pressure of the homogenization treatment in the fifth step is 0.05 to 0.06Mpa, and the homogenization treatment time is 2 min; the vacuum condition of the emulsification tank is-0.08 +/-0.01 MPa, and the maintaining time is 60 min.
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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6445308A (en) * 1987-08-12 1989-02-17 Yasuhiro Asai Dental cleaning material
US5149536A (en) * 1991-12-06 1992-09-22 Ratkus Victor L Dental root canal bacterialcidal lubricant
US5649825A (en) * 1996-03-01 1997-07-22 Ratkus; Victor L. Dental root canal bacterialcidal lubricant
CN101244012A (en) * 2007-02-14 2008-08-20 张郁 Lubricant agent for root canal treatment
CN101869534A (en) * 2009-04-22 2010-10-27 日进齿科材料(昆山)有限公司 Lubricant for root canal therapy
WO2012075539A1 (en) * 2010-12-08 2012-06-14 Matthew Athanassiadis Improved root canal paste
WO2015009809A1 (en) * 2013-07-16 2015-01-22 Wu Nian Mouth wash compositions for denture adhesive removal
CN105213200A (en) * 2015-10-14 2016-01-06 陕西恒远生物科技有限公司 A kind of lubricant for root canal
CN105616169A (en) * 2016-02-22 2016-06-01 浙江浙北药业有限公司 Water-soluble root canal lubricant and preparation method thereof

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6445308A (en) * 1987-08-12 1989-02-17 Yasuhiro Asai Dental cleaning material
US5149536A (en) * 1991-12-06 1992-09-22 Ratkus Victor L Dental root canal bacterialcidal lubricant
US5649825A (en) * 1996-03-01 1997-07-22 Ratkus; Victor L. Dental root canal bacterialcidal lubricant
CN101244012A (en) * 2007-02-14 2008-08-20 张郁 Lubricant agent for root canal treatment
CN101869534A (en) * 2009-04-22 2010-10-27 日进齿科材料(昆山)有限公司 Lubricant for root canal therapy
WO2012075539A1 (en) * 2010-12-08 2012-06-14 Matthew Athanassiadis Improved root canal paste
WO2015009809A1 (en) * 2013-07-16 2015-01-22 Wu Nian Mouth wash compositions for denture adhesive removal
CN105213200A (en) * 2015-10-14 2016-01-06 陕西恒远生物科技有限公司 A kind of lubricant for root canal
CN105616169A (en) * 2016-02-22 2016-06-01 浙江浙北药业有限公司 Water-soluble root canal lubricant and preparation method thereof

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