This standard specifies the pulp capping test method for oral materials. This standard is used to evaluate the biocompatibility of direct pulp capping materials with the dental pulp. The operation process required for the material in clinical application is also included in this evaluation. YY/T 0127.11-2001 Dentistry Preclinical evaluation of biocompatibility of medical devices for oral use Section 2: Biological test methods for oral materials Pulp capping test YY/T0127.11-2001 Standard download decompression password: www.bzxz.net

YY /T 0127. 11---2001
This standard adopts ISO7405:1997 "Dentistry-Preclinical evaluation of biocompatibility of medical devices used in dentistry-Test methods for dental materials" of the International Organization for Standardization.
This standard is mainly based on ISO7405:1997 "Dentistry-Test methods for materials" and refines the test steps.-Preclinical evaluation of biocompatibility of medical devices used in dentistry This standard is a part of YY/T0127 standard. In order to unify the name of ISO7405:1997 standard, the leading element in the name of this standard is "Dentistry-Preclinical evaluation of biocompatibility of medical devices used in dentistry". In addition, the leading elements of the name of the published YY/T0127 standard will also be modified accordingly when the standard is revised. This standard is proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Dental Materials and Instruments. This standard was drafted by the National Medical Products Administration Peking University Medical Device Quality Supervision and Inspection Center. The drafters of this standard are: Lin Hong, Liu Wenyi, Yue Lin. 61
YY/T0127.11—2001
ISOForeword
ISO (International Organization for Standardization) is a worldwide federation composed of national standardization groups (ISO member groups). The formulation of international standards is usually completed by ISO's technical committees. If a national group is interested in a standard project established by a technical committee, it has the right to participate in the work of the committee. Official or unofficial international organizations that maintain contact with ISO may also participate in the relevant work. ISO and the International Electrotechnical Commission (IEC) maintain a close cooperative relationship in the standardization of electrotechnical technology. The draft international standard adopted by the technical committee is submitted to the member groups for voting. The draft international standard must obtain the consent of at least 75% of the member groups participating in the vote before it can be published as an international standard. International Standard ISO7405 was jointly drafted by ISO/TC106 Dental Technical Committee and the World Dental Federation (FDI). This first edition of the International Standard replaces ISO/TR7405:1984, which has been technically revised and converted into this International Standard. Annexes A, B and C of this standard are for information only. This International Standard is about preclinical testing of dental materials for use in dental medical devices. It is developed from ISO/TR7405:1984 Biological evaluation of dental materials and its annexes and replaces ISO/TR7405. It should be used in conjunction with the ISO10993 series of standards on biological evaluation of medical devices.
This standard differs from ISO/TR7405 in a number of important respects. First, it contains some specific test methods that are applicable only to dental materials. Many of the test methods previously in ISO/TR7405 are now included in the ISO10993 series of standards and therefore details of these methods are not included in this standard. Second, only test methods for which the member countries of the committee have determined that there is sufficient published data are included in this standard. Third, when recommending test methods, the principle of minimizing the use of animals is taken into consideration. 62
Pharmaceutical Industry Standard of the People's Republic of China
Dentistry--Preclinical evaluation of biocompatibility of medical devices used in dentistry-Part 2:Biological evaluation test method of dental materials-Pulp capping testbzxz.net
1 Scope
This standard specifies the pulp capping test method for dental materials. YY/T 0127. 112001
neq IS0 7405:1997
This standard is used to evaluate the biocompatibility of direct pulp capping materials with the dental pulp. The operating procedures required for the material in clinical application are also included in this evaluation.
Note: This test can be used for pulp cutting test with slight modifications. 2 Referenced standards
The clauses contained in the following standards constitute the clauses of this standard through reference in this standard. When this standard was published, the versions shown were valid. All standards are subject to revision, and parties using this standard should explore the possibility of using the latest versions of the following standards. GB/T16886.2-2000 Biological evaluation of medical devices Part 2: Animal protection requirements 3 Test specimens
Prepare the test materials according to the manufacturer's requirements. If the manufacturer requires the use of other irrigants or reagents for hemostasis or special pulp wound treatment methods, follow the manufacturer's requirements.
4 Control materials
Sterile saline [0.9% (m/m)] and chemically pure calcium hydroxide. Mix the two into a paste before use. 5 Experimental animals
5.1 Animal protection should comply with
GB/T16886.2-2000 or national regulations on experimental animals. 5.2 One of monkeys, dogs or miniature pigs can be selected. At least one animal shall be used for each test cycle. The animal shall have complete permanent teeth (all permanent teeth except M3 have erupted) and the root apex shall be fully formed. Approved by the State Food and Drug Administration on November 9, 2001 and implemented on March 1, 2002
6 Test cycles
7 d±2 d and 70 d±5 d.
7 Test procedures
7.1 Animal preparation
YY/T 0127. 11—2001
Select enough animals to ensure that at least 7 teeth contain test materials in each test cycle. 7.2 Tooth preparation
7.2.1 General anesthesia shall be performed on the animal with a suitable anesthetic. All tartar and plaque on the tooth surface shall be removed. Use 1% iodine and 75% ethanol to disinfect the periorbital area. Use 3% (V/V) hydrogen peroxide to clean the crown surface, gums and soft tissues in the mouth. Place a rubber dam to isolate the teeth to be used. Disinfect the tooth surface and surgical area with a disinfectant containing iodine or chlorhexidine. Under water spray cooling, use a sharp drill to prepare a Class V cavity in the enamel area 1 mm away from the enamel-cementum junction on the buccal or labial neck of the tooth. The cavity should be covered with enamel all around and extend to the mesiodistal surface of the tooth, deep to the inner third of the dentin or until the bottom of the cavity is pink. Rinse the cavity with sterile saline [0.9% (m/m)]. In the center of the cavity, carefully prepare a pulp hole with a diameter of 0.5mm~1.0mm under the irrigation of sterile saline [0.9% (m/m)]. The drill cannot enter the pulp tissue (for example, a 1/2 ball with a diameter of 0.5mm can be used to drill the pulp cavity gently in the center of the cavity). Rinse the cavity thoroughly with sterile saline until bleeding stops. Wipe the cavity wall dry with a sterile cotton ball. If the manufacturer requires the use of other irrigants or reagents to stop bleeding or special pulp wound treatment methods, follow the manufacturer's requirements. Note: If the animal has obvious gingivitis, calculus and plaque should be removed 1 week before cavity preparation. If necessary, the above operation can be repeated until the gingivitis is controlled. 7.2.2 According to the random principle, at least 7 cavities are capped with the test material and 5 cavities are capped with the control material in each test cycle. Mix the test material and the control material on a sterile mixing board. Place the material on the exposed pulp hole without applying pressure. Use zinc oxide eugenol or zinc polycarboxylate cement as the base. Finally, composite resin or glass ionomer cement can be filled with bonding technology. 8 Postoperative Observation
8.1 During the test period, observe each animal regularly for reactions, such as changes in diet or inflammation or suppuration of oral tissues. 8.2 Section Preparation
8.2.1 After 7d±2d and 70d±5d, kill enough animals with an overdose of anesthetic to obtain at least 7 teeth containing the test material. Inspect the filling, tooth and its supporting tissue, and record any abnormal details. Cut each tissue block containing the tooth and its surrounding soft and hard supporting tissues and fix it with formalin or other suitable fixative. If the fixative is used to perfuse the tissue blood vessels before the animal is killed and the tissue block is cut, the fixation effect will be better. 8.2.2 After fixation, examine each tissue block with an X-ray to check whether there are any imaging changes. 8.2.3 Use a suitable decalcifying agent [such as 10% (V/V) formic acid or 0.5mol/L ethylenediaminetetraacetic acid (EDTA) solution]. Embed in paraffin and slice continuously. Continuously slice from the crown to the apex through the labial (buccal) and lingual surfaces of the tooth along the long axis of the tooth through the pulp foramen. The slice thickness is 5um to 10um. Slices are taken at intervals and stained with HE. If necessary, use appropriate bacterial staining methods (such as Brown & Brenn method) or other methods to check for microleakage to take additional slices for staining.
9 Pulp evaluation
Examine the slices and describe the histological characteristics. Blindly examine the slices. For each serial slice, describe and record in detail all the histological characteristics of the dentin, pulp and periapical tissues (the degree and extent of inflammatory infiltration, inflammatory cell types, changes in odontoblasts, congestion, pulp degeneration, the nature and extent of pulp necrosis, dentin bridge formation, etc.), including any histological changes that may be caused by cavity preparation. The degree of inflammatory infiltration of the pulp surface tissue (odontoblast layer, cell-free layer and multicellular layer) and deep pulp tissue were graded according to the following grading method.
No inflammation
Mild inflammation
Moderate inflammation
Severe inflammation
YY/T 0127. 11--2001
Abscess formation or spread to the periapical tissue area Inflammatory reaction indexes are calculated for both sites in each test cycle by adding the scores obtained for each section and dividing by the total number of sections observed. The reaction indexes of the teeth capped with the test material and the control group should be reported separately. In addition, the number of cavities containing bacteria is recorded in each test cycle, if necessary. In addition, dentin bridges are graded as none, partial, or complete. Evaluation of results
All information in the test should be considered in the evaluation of the results, especially any differences in the results between the test and control groups. The results are judged based on the comparison between the test and control groups. After 70 days ± 5 days, if there is no significant difference in tissue reaction caused by the test group and the control group, and there is no inflammation in the deep pulp, then the pulp capping of the test material is qualified.
The evaluation results shall be recorded in the test report. 11 Test Report
The test results shall be recorded in the test report, which shall contain a complete record of the procedures taken, all the results obtained and any other data necessary to assist in the evaluation of the results. A detailed record of the preparation and use of the test materials and the batch numbers of the materials shall also be included in the report.
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