Healing Wound
Conditions
Brief summary
This study will examine whether using PRF and your age are going to affect the healing and regeneration benefits gained from PRF.
Detailed description
Platelet-rich fibrin (PRF) is commonly used to enhance gum tissue healing and reducing pain after tooth extraction and before placing a dental implant. 44 patients requiring a tooth extraction will be recruited and randomized to receive a collagen plug with or without platelet-rich fibrin.
Interventions
PROCEDURESocket preservation
After tooth extraction, the extraction socket will be filled with a collagen plug in one group or a platelet-rich fibrin plug in the other.
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 (molars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable. 3. Non-infected sockets with intact buccal bone (≥1.5 mm in thickness measured through calipers) 4. Patients interested in implant placement following tooth extraction.
Exclusion criteria
1. Allergies or hypersensitivities to study related medications. 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, Long-term NSAIDs use, Steroid). 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. 12. Systemic diseases that compromise the immune system 13. Anti-coagulant therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alveolar ridge dimension changes | 4 months | Digitally measured alveolar ridge dimension changes in mm\^2 using cone-beam computed tomography |
| Soft tissue dimension changes | 4 months | Digitally measured soft tissue changes in mm\^2 using intraoral scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histological bone density. | 4 months | Histomorphometry. |
| Presence of bone turnover proteins. | 4 months | Immunohistochemistry. |
| Amount of growth factors | At baseline surgery | Growth factors (PDGF, VEGF and TGF b1) from PRF obtained from drawn blood |
| Wound healing index | 1 week, 2 weeks, 4 weeks, and 8 weeks | Wound healing index (WHI) according to the following scheme: Score "1" for uneventful wound healing with no gingival edema, erythema, suppuration, discomfort or barrier exposure; Score "2" for uneventful wound healing with slight gingival edema, erythema, or discomfort but no suppuration; Score "3" for poor wound healing with significant gingival edema, erythema, discomfort, loss of barrier or any suppuration. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMuhammad Saleh, BDS, MSD
University of Michigan
Outcome results
None listed