Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia.
Department of Oral Biology, Faculty of Dentistry, Hasanuddin University, Makassar, Indonesia.
JMIR Res Protoc. 2024 Jul 19;13:e49922. doi: 10.2196/49922.
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.
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.
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.
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.
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.
Indonesia Registry Center INA-D02FAHP; https://tinyurl.com/2jnf6n3s.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/49922.
拔牙手术常导致骨质吸收，这可能对牙槽嵴的尺寸产生不利影响。研究表明，使用骨代用物的牙槽窝保存技术可有效减少此类情况下的早期骨丢失。α-半水硫酸钙（α-CSH）具有骨诱导性、血管生成潜力和生物相容性等有利特性，已成为一种有前途的骨移植材料而备受关注。考虑到这些事实，我们制定了初步方案，以应用α-CSH 解决拔牙后牙槽骨丢失问题。
本研究的总体目标是评估α-CSH 作为拔牙后牙槽窝保存的骨诱导移植材料的可行性和初步效果。
本初步临床试验将纳入 30 名年龄在 18-35 岁之间的个体的新鲜拔牙窝。将参与者分为两组：一组在拔牙后接受α-CSH 移植材料进行牙槽窝保存，另一组不接受任何移植材料。在整个研究过程中，将对参与者进行密切监测以确保安全，包括临床检查、影像学检查和血液检查。将广泛使用影像学检查来协助评估骨形成的进展情况。
该研究于 2022 年 8 月开始招募参与者，并计划在 2023 年底完成所有评估和分析。预计 2024 年底可获得研究结果。
本临床研究是首次在人体中评估 α-CSH 在牙槽骨再生中的可行性和疗效。我们假设，α-CSH 的加入可以极大地加速新鲜牙槽窝内的骨形成过程，迅速恢复骨高度，而不会带来自体骨移植的缺点。
印度尼西亚注册中心 INA-D02FAHP；https://tinyurl.com/2jnf6n3s。
国际标准化组织注册报告识别码（IRRID）：DERR1-10.2196/49922。
