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CC BY 4.0 · Eur J Dent 2023; 17(04): 1289-1293
DOI: 10.1055/s-0043-1761186
Original Article

Determination of the Sterilization Dose of Gamma-Ray Irradiation for Polyvinyl Alcohol-Collagen-Chitosan Composite Membrane as a Material for Periodontal Regenerative Surgery

Agus Susanto
1   Department of Periodontics, Faculty of Dentistry, Universitas Padjadjaran, Bandung, Indonesia
,
Ira Komara 
1   Department of Periodontics, Faculty of Dentistry, Universitas Padjadjaran, Bandung, Indonesia
,
Maria Theresia Beatrix
1   Department of Periodontics, Faculty of Dentistry, Universitas Padjadjaran, Bandung, Indonesia
,
Fajar Lukitowati
2   Research Center for Radiation Process Technology—National Research and Innovation Agency (NRIA), Indonesia
,
Amaliya Amaliya 
1   Department of Periodontics, Faculty of Dentistry, Universitas Padjadjaran, Bandung, Indonesia
,
Ina Hendiani
1   Department of Periodontics, Faculty of Dentistry, Universitas Padjadjaran, Bandung, Indonesia
,
Aldilla Miranda
1   Department of Periodontics, Faculty of Dentistry, Universitas Padjadjaran, Bandung, Indonesia
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Abstract

Objective Membrane sterility is very necessary considering its function as an implant material. Therefore, this research aims to determine the dose of gamma-ray irradiation for the sterilization of polyvinyl alcohol (PVA)–collagen–chitosan composite membranes used as regenerative surgery materials.

Materials and Methods A total of 100 pieces of the composite membranes were prepared in a size of 2.0 × 1.5 cm by mixing 7.5% PVA, 3% collagen, and 2% chitosan using the film casting method in three batches. Furthermore, the bioburden test was performed to determine the initial microbial count in the sample by following ISO 11737-1. The results were used to ascertain the dose of gamma-ray irradiation on the sample according to ISO 11137-2. The dose verification test was then performed at the sterility assurance level 10−6.

Results The average result of the bioburden test from three batches was 6.6 colony forming unit; hence, the verification dose was 4.8 kGy. In the verification dose test, since there was only one contaminated sample, the sterility dose test was continued.

Conclusion The sterile gamma-ray irradiation dose for PVA–collagen–chitosan composite membrane was 17.1 kGy.

Keywords

PVA–collagen–chitosan - sterilization - gamma-ray irradiation


Publication History

Article published online:
27 June 2023

© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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