The Effectiveness of Carbonate Apatite Bone Graft for Alveolar Ridge Preservation

NCT07020650 | Enrolling By Invitation FDA Device

• 1 other identifier: HUM00267966
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healing Wound

Outcome Measures

Primary Outcomes (1)

• Clinical alveolar ridge dimension changes

  Clinically measured alveolar ridge dimension changes in mm

  4 months

Secondary Outcomes (3)

• Histological bone density

  4 months

• Presence of bone turnover proteins

  4 months

• Alveolar volumetric changes following tooth extraction

  4 months

Study Arms (3)

Synthetic bone

EXPERIMENTAL

Bone graft with carbonate apatite (Cytrans Granules)

Device: Socket preservation

Allograft

ACTIVE COMPARATOR

Bone graft with allograft (Puros)

Device: Socket preservation

Xenograft

EXPERIMENTAL

Bone graft with xenogeneic plug (BioOss)

Device: Socket preservation

Interventions

Socket preservation DEVICE

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

Allograft; Synthetic bone; Xenograft

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Hom-Lay Wang, DDS,MSD,PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collegiate Professor of Periodontics and Professor of Dentistry, Department of Periodontics and Oral Medicine, School of Dentistry

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)