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NCT Number: NCT07638319

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

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.

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Key information

Conditions

Tooth Extraction Alveolar Bone Grafting Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases Tooth Extraction Site Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Clinica Dentária Egas Moniz

Caparica, Monte Da Caparica, 2829-511, Portugal

Location status: Recruiting

Location contact

Angel Lobito, Masters' in Dentistry

CONTACT

[email protected]

00351924347050

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neocement Inject P® (Beta-Tricalcium Phosphate)

Device

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

Primary outcomes

  1. Change in alveolar ridge volume after tooth extraction

    Time frame: From enrollment to the end of treatment at 6 months

    Change in alveolar ridge volume after tooth extraction on sockets grafted with Beta-Tricalcium Phosphate

Study contacts

Contact information is provided by the study sponsor or research team.

Angel Lobito, Masters' in Dentistry

CONTACT

[email protected]

00351924347050

Sponsors and collaborators

Lead sponsor

Egas Moniz - Cooperativa de Ensino Superior, CRL

Other

Registry information

Official study title

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

Acronym: BTCPARPBV

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jun 10, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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