Feasibility and Preliminary Efficacy of α-Calcium Sulfate Hemihydrate in Socket Preservation: Protocol for a Pilot Randomized Controlled Trial.

Autor:	Ruslin M; Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia., Hamrun N; Department of Oral Biology, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia., Tajrin A; Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia.; Hasanuddin University Dental Hospital, Makassar, Indonesia., Yusuf ASH; Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia., Nurrahma R; Department of Prosthodontic, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia.; Department of Oral and Maxillofacial Surgery/Oral Pathology, Amsterdam University Medical Centers and Academic Centre for Dentistry Amsterdam, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, Netherlands., Natsir-Kalla DS; Department of Oral and Maxillofacial Surgery/Oral Pathology, Amsterdam University Medical Centers and Academic Centre for Dentistry Amsterdam, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, Netherlands.; Department of Biochemistry, Faculty of Medicine, Hasanuddin University, Makassar, Indonesia., Ariestiana YY; Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia., Nur Anam M; Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia., Liu CM; Department of Biomedical Engineering, College of Biomedical Engineering, China Medical University, Taichung, Taiwan., Ou KL; Graduate Institute of Dental Science, College of Dentistry, China Medical University, Taichung, Taiwan.; Department of Dentistry, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan.; 3D Global Biotech Inc (Spin-Off Company from Taipei Medical University), New Taipei City, Taiwan.; Department of Oral Hygiene Care, Ching Kuo Institute of Management and Health, Keelung, Taiwan.; Division of Clinical Cariology and Endodontology, Department of Oral Rehabilitation, School of Dentistry, Health Sciences University of Hokkaido, Hokkaido, Japan.
Jazyk:	angličtina
Zdroj:	JMIR research protocols [JMIR Res Protoc] 2024 Jul 19; Vol. 13, pp. e49922. Date of Electronic Publication: 2024 Jul 19.
DOI:	10.2196/49922
Abstrakt:	Background: Tooth extraction procedures often lead to bone resorption, which can have adverse effects on the dimensions of the alveolar ridge. Research has shown that socket preservation techniques using bone graft substitutes can effectively minimize early bone loss in such cases. α-calcium sulfate hemihydrate (α-CSH) has garnered significant attention as a potential bone graft material due to its favorable properties, including osteoconductivity, angiogenic potential, and biocompatibility. Considering these facts, we developed a preliminary protocol for applying α-CSH in addressing alveolar bone loss following tooth extraction. Objective: This research's general objective is to evaluate the feasibility and initial effectiveness of α-CSH as bone-inducing graft material for socket preservation after tooth extraction. Methods: This preliminary clinical trial will involve 30 fresh extraction sockets from individuals aged 18-35 years. The participants will be divided into 2 groups: one group will receive α-CSH graft material after tooth extraction for socket preservation, while the other group will not receive any graft material. Throughout the study, the participants will be closely monitored for safety measures, which will include clinical examinations, radiographic imaging, and blood tests. Radiographic imaging will be used extensively to assist the progress of bone formation. Results: The study commenced enrollment in August 2022 and is scheduled to conclude post assessments and analyses by the end of 2023. The results of the study are anticipated to be accessible in late 2024. Conclusions: This clinical study represents the initial investigation in humans to assess the feasibility and efficacy of α-CSH in alveolar bone regeneration. We hypothesize that the inclusion of α-CSH can greatly expedite the process of bone formation within fresh sockets, resulting in a swift restoration of bone height without the disadvantages associated with harvesting autogenous bone graft. Trial Registration: Indonesia Registry Center INA-D02FAHP; https://tinyurl.com/2jnf6n3s. International Registered Report Identifier (irrid): DERR1-10.2196/49922. (©Muhammad Ruslin, Nurlindah Hamrun, Andi Tajrin, Andi Sitti Hajrah Yusuf, Rifaat Nurrahma, Diandra Sabrina Natsir-Kalla, Yossy Yoanita Ariestiana, Mukhtar Nur Anam, Chung-Ming Liu, Keng-Liang Ou. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 19.07.2024.)
Databáze:	MEDLINE
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