Influence of Platelet-Rich Fibrin on Post-extraction Alveolar Ridge Healing/Preservation as a Stand-alone or Adjunct to Particulate Graft

Study Overview
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Brief Summary
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The goal of this project is to evaluate the influence of platelet rich fibrin (PRF) in extraction socket healing with or without particulate bone graft. The hypothesis of this study is that PRF will enhance the extraction socket healing and new bone formation when compared to extraction sockets grafted without PRF.

Official Title
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Influence of Platelet-Rich Fibrin on Post-extraction Alveolar Ridge Healing/Preservation as a Stand-alone or Adjunct to Particulate Graft: A Clinical, Radiographic and Histological Evaluation

Conditions
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Extraction Socket Healing, Alveolar Ridge Preservation

Intervention / Treatment
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* Procedure: Socket grafting with PRF
* Procedure: Socket grafting with bone graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects ≥ 18 years of age Hopeless or non-restorable single non-molar tooth per quadrant with adjacent teeth present Maximum of two teeth can qualify per patient. The buccal plate must be ≥ 1mm in width with a 4-wall configuration. Cases requiring minimal sinus grafting (<3mm) Bone grafting limited to the apical portion of the osteotomy site Exclusion Criteria: Exclusion Criteria: Untreated periodontal disease, endodontic-periodontal disease and/or caries The buccal plate must be ≤ 3mm in width with a 4-wall configuration. Patients with uncontrolled or severe systemic disease (Diabetes) Patients with medical conditions or taking medication associated with compromised bone healing (Diabetes, Autoimmune Dysfunction, Prolonged Cortisone Therapy, Chemotherapy, or Bisphosphonate Therapy) Current Smokers Subjects with extensive parafunctional habits (ie; bruxism) Subjects who demonstrate inadequate oral hygiene

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No socket grafting<br>Extraction with normal socket healing | |
| Active Comparator: Socket grafting with platelet rich fibrin (PRF) alone<br>Extraction with socket grafting with platelet rich fibrin (PRF) alone. | Procedure: Socket grafting with PRF<br>* Extraction with socket grafting using PRF.<br>|
| Active Comparator: Socket grafting with bone grafting alone<br>Extraction with socket grafting using bone graft (xenograft). | Procedure: Socket grafting with bone graft<br>* Extraction with socket grafting using bone graft.<br>|
| Active Comparator: Socket grafting with PRF and bone grafting<br>Extraction with socket grafting using PRF combined with bone graft (xenograft). | Procedure: Socket grafting with PRF<br>* Extraction with socket grafting using PRF.<br>Procedure: Socket grafting with bone graft<br>* Extraction with socket grafting using bone graft.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in alveolar ridge width (buccal-lingual) | Baseline is at the time of extraction with or without socket grafting. | baseline, 3 months | 
| Change in alveolar ridge height (apical coronal) | Baseline is at the time of extraction with or without socket grafting. | baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of vital bone in bone core as assessed histology | A bone core will be taken at 3 months after socket grafting. | 3 months | 
| Percentage of residual bone graft in bone core as assessed histology | A bone core will be taken at 3 months after socket grafting. | 3 months |