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Assessment of the Impact of Neocement Inject P® (Beta-Tricalcium Phosphate) on Bone Volume in Alveolar Ridge Preservation After Tooth Extraction

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07638319
Acronym
BTCPARPBV
Enrollment
30
Registered
2026-06-10
Start date
2025-12-01
Completion date
2028-12-01
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Grafting, Alveolar Bone Loss, Tooth Extraction, Tooth Extraction Site Healing

Keywords

Beta-tricalcium phosphate, Alveolar ridge preservation, Bone volume, Implant site development, Socket preservation, Ridge augmentation, Tooth extraction, Volumetric Changes

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.

Interventions

DEVICENeocement Inject P® (Beta-Tricalcium Phosphate)

After tooth extraction the socket will be grafted with Neocement Inject P® (Beta-Tricalcium Phosphate).

Sponsors

Egas Moniz - Cooperativa de Ensino Superior, CRL
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in alveolar ridge volume after tooth extractionFrom enrollment to the end of treatment at 6 monthsChange in alveolar ridge volume after tooth extraction on sockets grafted with Beta-Tricalcium Phosphate

Countries

Portugal

Contacts

CONTACTAngel Lobito, Masters' in Dentistry
alobito@egasmoniz.edu.pt00351924347050
STUDY_DIRECTORJoão Botelho, PhD in Biomedical Sciences

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026