NCT07638319 Assessment of the Impact of Neocement Inject P® (Beta-Tricalcium Phosphate) on Bone Volume in Alveolar Ridge Preservation After Tooth Extraction
| NCT ID | NCT07638319 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Egas Moniz - Cooperativa de Ensino Superior, CRL |
| Condition | Tooth Extraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-12-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 measure horizontal and vertical resorption and bone density.
Eligibility Criteria
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
Contact & Investigator
João Botelho, PhD in Biomedical Sciences
STUDY DIRECTOR
Clinical Research Unit (CRU), Egas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science
Frequently Asked Questions
Who can join the NCT07638319 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tooth Extraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07638319 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07638319 currently recruiting?
Yes, NCT07638319 is actively recruiting participants. Contact the research team at alobito@egasmoniz.edu.pt for enrollment information.
Where is the NCT07638319 trial being conducted?
This trial is being conducted at Caparica, Portugal.
Who is sponsoring the NCT07638319 clinical trial?
NCT07638319 is sponsored by Egas Moniz - Cooperativa de Ensino Superior, CRL. The principal investigator is João Botelho, PhD in Biomedical Sciences at Clinical Research Unit (CRU), Egas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science. The trial plans to enroll 30 participants.