The Effectiveness of Carbonate Apatite Bone Graft for Alveolar Ridge Preservation

University of Michigan

Status: Invitation-only

Conditions: Healing Wound

Treatments: Procedure: Socket preservation

Study type: Interventional

Funder types: Other

Identifiers

NCT07020650

HUM00267966

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Synthetic bone

Experimental group

Description:

Bone graft with carbonate apatite (Cytrans Granules)

Treatment:

Procedure: Socket preservation

Allograft

Active Comparator group

Description:

Bone graft with allograft (Puros)

Treatment:

Procedure: Socket preservation

Xenograft

Experimental group

Description:

Bone graft with xenogeneic plug (BioOss)

Treatment:

Procedure: Socket preservation