Bovine-derived Xenograft With or Without L-PRF for Alveolar Ridge Preservation After Tooth Extraction: a Randomized Controlled Trial

Study Overview
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Brief Summary
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The study is prospective randomized clinical trial that aims to evaluate the adjunctive use of L-PRF in promoting the desired vascularization and bone fill in small and large defects following tooth extraction and report on the long-term implant and patient outcomes

Official Title
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Bovine-derived Xenograft (Bio-Oss Collagen) With or Without Leukocyte-platelet Rich Fibrin (L-PRF) for Alveolar Ridge Preservation After Tooth Extraction: a Randomized Controlled Trial

Conditions
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Dental Implants, Tooth Extraction, Bone Regeneration

Intervention / Treatment
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* Procedure: Alveolar ridge preservation using sticky bone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 or over. Require extraction of anterior or posterior single tooth due to caries, endodontic and prosthetic complications. The tooth that requires extraction is bordered by two teeth. Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline). Good compliance and commitment to attend follow-up review appointments. Willing to provide informed consent. Exclusion Criteria: Localised / generalised periodontitis. Presence of acute periapical lesion. Bone metabolic disease and/or taking medications that affect bone metabolism. Long term use of non-steroidal anti-inflammatory medications. History of malignancy, radiotherapy or chemotherapy. Pregnant or lactating women. Severe bruxism or parafunctional habits. Large occlusal discrepancies.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group (C)<br>Xenograft + resorbable collagen membrane | Procedure: Alveolar ridge preservation using sticky bone<br>* In the test group the xenograft will be mixed in with the L-PRF then placed into the socket.<br>|
| Experimental: Test group (T)<br>Xenograft combined with L-PRF + resorbable collagen membrane | Procedure: Alveolar ridge preservation using sticky bone<br>* In the test group the xenograft will be mixed in with the L-PRF then placed into the socket.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival / success rate will be assessed clinically after one year of implant restoration and annually up to three years. |  | 2 years | 
| Patient postoperative experience will be assessed using visual analogue scale during the first week following tooth extraction and ridge preservation. | Reporting a score will be done using the pain visual analogue scale. Minimum value is 0 which is no pain and maximum value is 10 which is the worst pain ever experienced. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in width and height of alveolar ridge will be assessed at the time of tooth extraction and ridge preservation, six months (prior to implant placement) and annually up to two years using cone beam computed tomography (CBCT). |  | 2 years | 
| Need for additional bone augmentation will only be assessed at the time of implant placement by recording the use of bone graft (if required) in the clinical notes. |  | 2 years | 
| Changes in peri-implant marginal bone level will be assessed at implant placement (baseline) and after one year of implant restoration and annually up to two years using standardized peri-apical radiograph. |  | 2 years | 
| Soft tissue levels (midbuccal marginal tissue level changes, interproximal papilla level changes and changes in width of keratinised tissue) will be assessed at implant placement (baseline), at 1 year and at 2 years |  | 2 years | 
| Biological complications (i.e. peri-implant diseases) will be assessed clinically using periodontal probe after one year of implant restoration and annually up to two years. |  | 2 years |