Healing Wound
Conditions
Brief summary
This study will examine whether adding an amnion-chorion membrane on top of the traditionally used collagen plug will lead to more bone formation compared to the collagen plug only.
Detailed description
Bone grafts and membranes are commonly placed to increase the amount of bone right after tooth extraction and before placing a dental implant. The primary objective of this study is to study the effect of a human amnion-chorion membrane (ACM) in an exposed-barrier ridge preservation technique to a control group without utilizing a ACM. 30 patients requiring a front tooth extraction will be recruited and randomized to receive bone grafting with or without an ACM.
Interventions
PROCEDURESocket preservation
After tooth extraction, the socket will be filled with a collagen plug and covered with an amnion-chorion membrane.
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
1. Age range: 20 to 80 years. 2. Patients must require tooth extraction (for incisors, canines and premolars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable. 3. Socket should be free of infection, less than 5mm of dehiscence 4. Patients interested in implant placement following tooth extraction.
Exclusion criteria
1. Allergies or hypersensitivities to study related medications such as chlorhexidine. 2. Hematologic disorders/blood dyscrasias. 3. Active infectious diseases of any kind. 4. Liver or kidney dysfunction/failure. 5. Uncontrolled diabetes (HbA1c \> 8). 6. Active cancer treatment - such as active chemotherapy or radiation therapy. 7. Taking medications that will affect their bone healing (for example, bisphosphonates). 8. Metabolic bone diseases that affect bone healing such as osteoporosis. 9. Pregnant or lactating women (self-reported). 10. Smoke 10 or more cigarettes per day (self-reported). 11. Poor oral hygiene.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical alveolar ridge dimension changes | 4 months | Clinically measured alveolar ridge dimension changes in mm using calibers |
| Digital alveolar ridge dimension changes | 4 months | Digitally measured alveolar ridge dimension changes in mm2 using CBCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant survival-Clinical | 6 months | Clinically assessed by torque test using a torque wrench, measured in N/cm. |
| Histological bone density. | 4 months | Histomorphometry. |
| Esthetic restorative outcomes. | 6 months | Clinical changes in hard tissue based on the PES score |
| Implant survival-Radiographic | 6 months | Radiographically assessed through any signs of radiolucency around the implant. |
| Presence of bone turnover proteins. | 4 months | Immunohistochemistry. |
Countries
United States
Outcome results
None listed