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Enrolling by invitation NCT07020650

The Effectiveness of Carbonate Apatite Bone Graft for Alveolar Ridge Preservation

No phase Interventional Healing Wound

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Socket preservation.
Who it may be relevant to
Registry conditions: Healing Wound. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Clinical alveolar ridge dimension changes [Time frame: 4 months]
Secondary outcome measures (3)
  • Histological bone density [Time frame: 4 months]
  • Presence of bone turnover proteins [Time frame: 4 months]
  • Alveolar volumetric changes following tooth extraction [Time frame: 4 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Michigan School of Dentistry — Ann Arbor

Identifiers

NCT: NCT07020650 · HUM00267966

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗