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Enrolling by Invitation

NCT Number: NCT07020650

The Effectiveness of Carbonate Apatite Bone Graft for Alveolar Ridge Preservation

This study will examine whether the use of synthetic carbon apatite bone graft material will lead to more bone formation compared to human derived allograft and bovine derived xenograft material.

Enrolling by Invitation

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

Bone grafts are commonly placed to increase the amount of bone right after tooth extraction and prepare the site for future dental implant placement.

45 patients requiring a tooth extraction will be recruited and randomized to receive either allograft, xenograft, or synthetic bone grafting.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 20 and 80 years old
  • Patients requiring tooth extraction (incisors, canines, and premolars) due to caries, periodontal disease, tooth fracture, or unrestorable condition.
  • Extraction sockets must be infection-free with dehiscence less than 5mm.
  • Patients interested in implant placement after tooth extraction.

Exclusion criteria

  • Known allergies or hypersensitivities to medications related to the study (e.g., chlorhexidine)
  • Hematologic disorders or blood dyscrasias.
  • Active infectious diseases.
  • Liver or kidney dysfunction/failure.
  • Uncontrolled diabetes (i.e., HbA1c > 8).
  • Undergoing active cancer treatment, including chemotherapy or radiotherapy within the last 12 months from the procedure.
  • Use of medications affecting bone healing (e.g., bisphosphonates, long-term anti-inflammatory medications).
  • Metabolic bone diseases affecting bone healing, such as osteoporosis (self-reported).
  • Pregnant or lactating women (self-reported).
  • Current smokers of 10 or more cigarettes per day and former smokers who quit less than 10 years ago (self-reported).
  • Poor oral hygiene.
  • Presence of fenestration defects equal to or greater than 5mm.

Treatment and study plan

Socket preservation

Device

After tooth extraction, the socket will be filled with a collagen plug and bone graft.

Primary outcomes

  1. Clinical alveolar ridge dimension changes

    Time frame: 4 months

    Clinically measured alveolar ridge dimension changes in mm

Secondary outcomes

  1. Histological bone density

    Time frame: 4 months

    Histomorphometry

  2. Presence of bone turnover proteins

    Time frame: 4 months

    Immunohistochemistry

  3. Alveolar volumetric changes following tooth extraction

    Time frame: 4 months

    Digitally measured alveolar ridge changes in mm^3 using CBCT

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

The Effectiveness of Carbonate Apatite Bone Graft for Alveolar Ridge Preservation: A Clinical, Radiographic, and Histomorphometric Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 13, 2025
Registry last updated
Mar 24, 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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