NCT07638358

Brief Summary

The goal of this randomized clinical trial is to assess whether BCP (Biphasic Calcium Phosphate) improves alveolar ridge preservation (ARP) in patients who need tooth extraction. The main question it aims to answer is whether using BCP for alveolar ridge preservation has a positive effect on bone volume compared with natural healing. The main questions it aims to answer are: Does BCP improve ridge preservation compared with natural healing? Researchers will compare BCP grafted sockets to natural healing sockets to see if BCP better preserves ridge volume. Participants will: Have a tooth indicated for extraction. Be assigned to either BCP 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
30mo left

Started Dec 2025

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Dec 2025Dec 2028

Study Start

First participant enrolled

December 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 5, 2026

Last Update Submit

June 9, 2026

Conditions

Alveolar Ridge PreservationTooth Extraction Site Healing

Keywords

Alveolar Ridge PreservationBiphasic Calcium PhosphateTooth ExtractionVolumetric ChangesImplant site developmentBone volumeSocket preservationRidge augmentation

Outcome Measures

Primary Outcomes (1)

  • Change in alveolar ridge volume after tooth extraction

    Change in alveolar ridge volume after tooth extraction on sockets grafted with Biphasic Calcium Phosphate

    From enrollment to the end of treatment at 6 months

Study Arms (1)

Neobone® (Biphasic Calcium Phosphate)

EXPERIMENTAL

After tooth extraction the socket will be grafted with Neobone® (Biphasic Calcium Phosphate)

Device: Neobone® (Biphasic Calcium Phosphate)

Interventions

Neobone® (Biphasic Calcium Phosphate)DEVICE

After tooth extraction the socket will be grafted with Neobone® (Biphasic Calcium Phosphate)

Neobone® (Biphasic Calcium Phosphate)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Acceptance of informed consent
  • Type 1 or 2 extraction sockets (Elian et al. 2007)

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Dentária Egas Moniz

Caparica, Monte Da Caparica, 2829-511, Portugal

RECRUITING

Related Publications (1)

  • Mishchenko O, Yanovska A, Kosinov O, Maksymov D, Moskalenko R, Ramanavicius A, Pogorielov M. Synthetic Calcium-Phosphate Materials for Bone Grafting. Polymers (Basel). 2023 Sep 19;15(18):3822. doi: 10.3390/polym15183822.

    PMID: 37765676BACKGROUND

Study Officials

  • João Botelho, PhD in Biomedical Sciences

    Clinical Research Unit (CRU), Egas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science

    STUDY DIRECTOR

Central Study Contacts

Angel Lobito, Masters' in Dentistry

CONTACT

00351924347050alobito@egasmoniz.edu.pt

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 10, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)