Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 18 and up

Bone-preserving grafting with Biphasic Calcium Phosphate after tooth extraction

Official title: Assessment of Safety and Performance of Neobone®: A Prospective Observational Study in the Field of Dentistry

Run by Egas Moniz - Cooperativa de Ensino Superior, CRL · NCT07638358 · Data updated 2026-11-12

This trial tests whether Neobone biphasic calcium phosphate grafts help preserve bone volume in tooth extraction sites compared with natural healing.

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorEgas Moniz - Cooperativa de Ensino Superior, CRL
Academic / other
Locations1 site (Caparica, Monte Da Caparica)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedDecember 2026
Study endsDecember 2028
Registry record updatedJune 11, 2026
Trial IDNCT07638358 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years or older needing a tooth extraction with a suitable extraction socket (types 1 or 2) who are willing to participate and provide informed consent.

Probably not a fit

Patients who heal similarly with natural bone regeneration or who have risk factors arising during the study may not benefit from the graft.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized early-phase study compares using Neobone biphasic calcium phosphate to allow natural healing after tooth extraction. Participants will have CBCT and intra-oral scans at baseline and after six months to measure changes in ridge width, height, and bone density. Outcomes focus on whether the graft helps maintain/better preserve alveolar ridge volume for future implant sites. The study includes adults requiring extraction and excludes those with active infection, poor oral hygiene, uncontrolled diabetes, heavy smoking, or other risk factors for implant surgery. Data will inform whether this graft material improves bone preservation over standard healing.

Why it matters

Potential benefit: If successful, the graft could improve preservation of the extraction site, potentially making future implants easier and more predictable.

How similar studies have gone: Previous work in bone grafting materials has shown variable success; this study explores a specific biphasic calcium phosphate product in a controlled randomized setting.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Clinica Dentária Egas Moniz
    Caparica, Monte Da Caparica, Portugal
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.