Assessment of the Impact of Neocement Inject P® (Beta-Tricalcium Phosphate) on Bone Volume in Alv… (NCT07638319) | Clinical Trial Compass
RecruitingEarly Phase 1
Assessment of the Impact of Neocement Inject P® (Beta-Tricalcium Phosphate) on Bone Volume in Alveolar Ridge Preservation After Tooth Extraction
Portugal30 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in alveolar ridge volume after tooth extraction
Timeframe: From enrollment to the end of treatment at 6 months
Trial details
NCT IDNCT07638319
SponsorEgas Moniz - Cooperativa de Ensino Superior, CRL