Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft

Study Overview
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Brief Summary
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Evaluation of two dressing materials; a Platelet-Rich Fibrin (PRF) dressing and a non-eugenol-based (Coe-Pak™) dressing in the management of free gingival graft and donor site palatal wound.

Detailed Description
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Evaluation of the usage of platelet-rich fibrin dressing in the management of free gingival graft and donor site palatal wound by evaluation of pain score, healing tissue in both donor and receiving sites, coverage of gingival recession, and the gain of attached gingiva. A total of 20 subjects will be invited to participate in this study from the patients seeking treatment at the Department of Periodontology, Faculty of Dentistry, Damascus University. The study has been approved by the investigator's local Review Board. Subjects will be recruited according to specific inclusion criteria. After completion of medical and dental history questionnaires, patients will sign a consent form after being advised about the nature of the study. Patients will be allocated into two groups (10 patients each). A Platelet-Rich Fibrin (PRF) dressing will be used in both donor and receiving sites in the test group, while a non-eugenol-based (Coe-Pak™) dressing will be used in both donor and receiving sites in the control group . Donor site working time, bleeding (BLE), colour match (CM), pain and re-epithelization (EP) will be evaluated.

Official Title
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Evaluation of the Usage of Platelet-Rich Fibrin Dressing in the Management of Free Gingival Graft and Donor Site Palatal Wound

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: A free gingival graft
* Device: A Platelet-Rich Fibrin dressing
* Device: A non-eugenol-based dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of Syrian descent. Systemically healthy. Attached gingival width ≤ 2 mm. Presence of type II (Miller Classification) of gingival recession. Exclusion Criteria: Smoking. Pregnancy or lactating. Presence of any systematic diseases can affect the periodontal surgery. Subjects with significant moderate to severe periodontal disease. Patients under orthodontic treatment Presence of restorative materials (e.g. crown) Subjects have failed to maintain good plaque control. Subjects having previous surgical treatment for covering the recession in the chosen area.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A Platelet-Rich Fibrin dressing<br>A Platelet-Rich Fibrin dressing (PRF) will be used in both donor and receiving sites after a free gingival graft. | Procedure: A free gingival graft<br>* A free gingival graft will be used for the treatment of gingival recession<br>Device: A Platelet-Rich Fibrin dressing<br>* A Platelet-Rich Fibrin dressing (PRF) will be applied in both donor and receiving sites after the free gingival graft.<br>|
| Experimental: A non-eugenol-based dressing<br>A non-eugenol-based dressing (Coe-Pak™) will be used in both donor and receiving sites after a free gingival graft. | Procedure: A free gingival graft<br>* A free gingival graft will be used for the treatment of gingival recession<br>Device: A non-eugenol-based dressing<br>* A non-eugenol-based dressing (Coe-Pak™) will be applied in both donor and receiving sites after the free gingival graft.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pain score using the visual analogue scale (VAS) | This variable is going to be measured by an visual analogue scale (VAS). The VAS pain scores ranges between 0 to10. (0: no pain, 1: minimal pain, 10: severe pain). | The Pain score will be evaluated twice. At T1 (after 2 days of surgery) and T2 (after 7 days of surgery). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing index for free gingival graft | The healing index for free gingival graft is an ordinal score: very poor, poor, good, very good and excellent. | The healing index will be evaluated twice. At T1 (after one week of surgery) and T2 (after one month of surgery).. | 
| The complete re-epithelialization of the palatal wound | This variable is going to be measured using the peroxide test. Scores are yes or no for showing bubbles. | The measurements will be performed at T1 (after 1 week measurement), T2 (after 2 weeks measurement), T3 (after 3 weeks measurement), and T4 (after 4 weeks measurement). | 
| Changes in gingival recession | Miller Class II of Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues. | The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement). | 
| Match color of the palatal wound | VAS scores (between 0 and 10. 0: no CM, 10: excellent CM) in comparison with adjacent and contralateral palatal mucosa. | The measurement will be performed at T1 (after 1 week measurement) and T2 (after 1 month measurement). | 
| Attached gingival width | Measured from the Mucogingival junction to the gingival Groove. | The measurement will be performed at T0 (baseline measurement) and at T1 (after 3 months measurement). | 
| Plaque index | Score: none, simple, middle, severe. | The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement). | 
| Gingival Index | Score: none, simple, middle. Severe. | The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement). | 
| Bleeding on probing Index | Score: bleeding, none bleeding. | The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement). | 
| Pocket Probing Depth | Score: normal, simple, middle, severe. | The measurement will be performed at T0 (baseline measurement) and at T1 (at three months exactly post-operatively measurement). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autografts, gingival recession, free gingival graft, Attached gingival width, Platelet-Rich Fibrin dressing