Feasibility and Preliminary Efficacy of α–Calcium Sulfate Hemihydrate in Socket Preservation: Protocol for a Pilot Randomized Controlled Trial
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.029 | 0.024 |
| Meta-epidemiology (narrow) | 0.005 | 0.002 |
| Meta-epidemiology (broad) | 0.007 | 0.004 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.003 | 0.003 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.006 | 0.006 |
| Insufficient payload (model declined to judge) | 0.040 | 0.007 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".