Healing Wound
Conditions
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.
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
DEVICESocket preservation
After tooth extraction, the socket will be filled with a collagen plug and bone graft.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical alveolar ridge dimension changes | 4 months | Clinically measured alveolar ridge dimension changes in mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histological bone density | 4 months | Histomorphometry |
| Presence of bone turnover proteins | 4 months | Immunohistochemistry |
| Alveolar volumetric changes following tooth extraction | 4 months | Digitally measured alveolar ridge changes in mm\^3 using CBCT |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHom-Lay Wang, DDS,MSD,PhD
University of Michigan
Outcome results
None listed