Assessment of the Impact of Neocement Inject P® (Beta-Tricalcium Phosphate) on Bone Volume
The goal of this randomized clinical trial is to assess whether β-TCP (Beta-Tricalcium Phosphate) improves alveolar ridge preservation (ARP) in patients who need tooth extraction. The main question it aims to answer is whether using β-TCP for alveolar ridge preservation has a positive effect on bone volume compared wit
| Condition(s) | Tooth Extraction, Tooth Extraction Site Healing, Alveolar Bone Grafting, Alveolar Bone Loss |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | The goal of this randomized clinical trial is to assess whether β-TCP (Beta-Tricalcium Phosphate) improves alveolar ridge preservation (ARP) in patients who need tooth extraction. The main question it aims to answer is whether using β-TCP for alveolar ridge preservation has a positive effect on bone volume compared with natural healing. The main questions it aims to answer are: Does β-TCP improve ridge preservation compared with natural healing? Researchers will compare β-TCP grafted sockets to natural healing sockets to see if β-TCP better preserves ridge volume. Participants will: Have a tooth indicated for extraction. Be assigned to either β-TCP or natural healing. Undergo CBCT (Cone Beam Computed Tomography) and intra-oral scanning after extraction and after six months of healing to me |
| Who can participate | Inclusion Criteria: * 18 years or older * Acceptance of informed consent * Type 1 or 2 extraction sockets (Elian et al. 2007) Exclusion Criteria: * Presence of active infection or severe inflammation in the intervention zone * Relevant medical history that contraindicates implant surgery * Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score \>15%) and lack of motivation * Uncontrolled diabetes (reported levels of glycated haemoglobin exceeding 7%) * Uncontrolled and /or untreated periodontal disease * Heavy smokers (more than 10 cigarettes per day) * Immunosuppression |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Egas Moniz - Cooperativa de Ensino Superior, CRL |
| Locations | Caparica, Monte Da Caparica, Portugal |
| Start date | 2025-12-01 |
| NCT ID | NCT07638319 |
| Official listing | https://clinicaltrials.gov/study/NCT07638319 |