PRF for Treating Maxillary Gingival Recession

Study Overview
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Brief Summary
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This is a split-mouth, randomized, controlled clinical trial that aims to evaluate the clinical efficacy of platelet-rich fibrin (PRF) membranes in conjunction with coronally advanced flap (CAF) in treating maxillary gingival recession defects.

Official Title
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PRF for Treating Maxillary Gingival Recessions: A Split-mouth, Randomized, Controlled Clinical Trial

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Gingival coverage using coronally advanced flap and a connective tissue graft
* Procedure: Gingival coverage using coronally advanced flap and platelet rich fibrin membranes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than 18 years old Bilateral Miller class I + II recession in the upper jaw Exclusion Criteria: Smokers Patients with systemic diseases that could interfere with the healing Patients undergoing bisphosphonate therap .Patients who previously received radiation therapy of the jaws.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: coronally advanced flap with connective tissue graft<br>After randomization a subepithelial connective tissue graft along with coronally advanced flap is applied to one maxillary quadrant to cover the recession. | Procedure: Gingival coverage using coronally advanced flap and a connective tissue graft<br>* A coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using a subepithelial connective tissue graft<br>|
| Experimental: coronally advanced flap with platelet rich fibrin membranes<br>After randomization platelet rich fibrin membranes along with coronally advanced flap are applied to the other maxillary quadrant to cover the recession. | Procedure: Gingival coverage using coronally advanced flap and platelet rich fibrin membranes<br>* A coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using platelet rich fibrin membranes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in gingival height (recession coverage) | The measurements of the increase in gingival height (recession coverage) using a linear evaluation (corono-apical direction) with a periodontal probe (Merrit-B; Hu-Friedy, Chicago, IL, USA) at the interventions sites to the nearest 0.5 mm. Registration of the recession height was done before treatment and after 6 weeks. | six weeks | 
| Shrinkage in gingival height | To assess the shrinkage of the gingival height, the amount of gingival height vestibular to the treated teeth in a corono-apical direction was measured after the surgery and after six months. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain visual analog scores (VAS) and surgery time | This questionnaire used 100 mm visual analog scores VAS to evaluate the amount of pain, ranging from 0 (no pain) to 10 (worst pain imaginable), and the amount of swelling. Patients were asked to fill in the VAS scales at day 7 and day 14 at suture removal. The time of surgery was measured of both treatment options. Timing started at the moment of first incision until the last suture. | two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gingival recession, connective tissue graft, PRF membrane