Feasibility and preliminary efficacy of alpha-calcium sulfate hemihydrate (α-CSH) in socket preservation: Study protocol for a pilot randomized control trial (Preprint)

Abstract

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. Alpha-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 who are 18 years of age or older. The participants will be divided into two 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 utilized 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 early 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.

The clinical trial protocol was approved by the ethical committee of Faculty of Medicine, Hassanudin University-Makassar, Indonesia [protocol number 504/UN4.6.4.5.31/PP36/2022]. The trial has been registered at the Indonesian Trial Registry under number INA-D02FAHP since 24 October 2022 [www.ina-registry.org].