Use of Platelet Rich Fibrin in Addition to CAF and SCTG for Treatment of Gingival Recession

Study Overview
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Brief Summary
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This research will be conducted in an attempt to achieve complete root coverage with physiologic probing depth and a harmonious view with the adjacent tissues using Platelet rich fibrin in conjunction with Coronally advanced flap and subepithelial connective tissue graft.

Detailed Description
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The study population will be divided into 2 groups: Group 1: Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft. The patients should be non-smoker, medically free and above 18 years Group 2: Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft and platelet rich fibrin. the patients should meet the same inclusion criteria mentionned above.

Official Title
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The Use of Coronally Advanced Flap and Subepithelial Connective Tissue Graft With or Without Platelet Rich Fibrin in the Treatment of Miller Class I or II Gingival Recession: a Randomized Clinical Trial

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: CAF +SCTG
* Other: platelet rich fibrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 1) Patients 18 years and older 2) Buccal recession defects classified as either Miller class I or II gingival recession. 3) Clinical indication and/or patient request for recession coverage 4) Good oral hygiene Exclusion Criteria: - 1) Miller Class III and IV gingival recession. 2) Any systemic diseases or any medication. 3) Pregnancy. 4) Patients undergoing radiotherapy. 5) Handicapped and mentally retarded patients. 6) Current and former smokers as smoking is a contra-indication for plastic periodontal surgery . 7) Teeth with cervical restorations, abrasion

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAF+SCTG+PRF<br>The patients suffering from class I or II gingival recession in the intervention group will receive a subepithelial connective tissue graft (SCTG) covered by platelet rich fibrin membrane (PRF) followed by a coronally advanced flap (CAF) | Procedure: CAF +SCTG<br>* the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession<br>* Other names: CTG;Other: platelet rich fibrin<br>* in addition to coronally advanced flap and sub-epithelial connective tissue graft, PRF is also used in the surgical procedure to cover gingival recession<br>* Other names: PRF;|
| Active Comparator: CAF+SCTG<br>Control group patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG only | Procedure: CAF +SCTG<br>* the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession<br>* Other names: CTG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recession Depth | measured from the cemento-enamel junction to the margin of the gingiva at the mid-buccal point of the teeth at basline, 3 months and 6 months. It is recorded in millimeters (mm) with lower values mean better outcome. | baseline-3 months-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recession Width | It was measured as the distance from mesial and distal papillae along the CEJ. It is recorded in millimeters (mm) where lower values means a better outcome. | baseline-3 months-6 months | 
| Root Coverage Gain | (preoperative vertical recession - postoperative vertical recession/preoperative vertical recession) x 100. | at 6 months | 
| Probing Depth | measured from the gingival margin to the base of the pocket probe at the midbuccal point of the teeth. Its is recorded in millimeters (mm) where lower values mean better outcome. | baseline-3 months-6 months | 
| Clinical Attachment Level | measured from the CEJ to the base of the sulcus at the midbuccal point of the teeth. Its is recorded in millimeters (mm). | baseline-3 months-6 months | 
| Gingival Biotype | under local anesthesia from 3 mm below the gingival margin trans-gingivally piercing tissues horizontally, perpendicular to the long axis of the tooth until it contacts bone. Its is recorded in millimeters (mm) where higher values mean better outcome. | baseline-3 months-6 months | 
| Width of Keratinized Gingiva | from the margin of the gingiva to the mucogingival junction at the midbuccal point of the teeth. Its is reported in millimeters where higher values mean better outcome. | baseline-3 months-6 months | 
| Patient Satisfaction | printed yes/ no questionnaire with 3 questions: would you do this surgery again? would you recommend this treatment to others? are you satisfied with the results? | questionnaire given to the patient 6 months after the surgery | 
| Root Coverage Esthetic Score (RES) | The RES system evaluates 5 variables 6 months after surgery: Zero, 3, or 6 points are used for the evaluation of the position of the gingival margin (GM). A score of 0 or 1 point is used for each of the following variables: marginal tissue contour (MTC), soft tissue texture (STT), mucogingival junction (MGJ) alignment, and gingival color (GC). the points are then summed up to obtain one figure representing the RES. minimum value:0 maximum value: 10 which means better outcome for RES | 6 months | 
| Post Operative Pain | Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worstpain imaginable') for the first 2 weeks postoperatively | after 2 weeks from surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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root coverage