Platelet Rich Fibrin on Root Coverage of Gingival Recessions

Study Overview
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Brief Summary
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Several surgical techniques and various adjunctive agents have been used to covered Gingival Recession (GR) and promote clinical outcomes. The treatment of the GR more used (gold standard) is the root coverage with surgical procedures and connective tissue graft, but it has limitations due to the conditions of the donor graft. Is necessary develop other biomaterials for these cases. The platelet rich fibrin is a autologous biomaterial that has gained tremendous momentum having been utilized for a variety of dental and medical procedures including periodontal surgeries. However, results remain contradictory and mainly focus on the hard and soft tissue healing, aesthetics and postoperative discomfort. The objective of this study was to evaluate the clinical effects of coronal advanced flap (CAF) and CAF + Platelet Rich Fibrin (PRF) on Root coverage (RC) over a period of 24 month.

Official Title
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Clinical Evaluation of Coronal Advanced Flap and Platelet Rich Fibrin on Root Coverage of Gingival Recessions Over a Period of 24 Month.

Conditions
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Gingival Recession

Intervention / Treatment
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* Other: Platelet rich fibrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study Healthy males and females of age 18-60 years old Multiple bilateral (maxillary or mandibular) gingival recessions (Miller class І or II) Good oral hygiene (O´Leary index ≤ 15%) Exclusion Criteria: Active periodontal disease Periodontal surgeries in the last three years Pregnancy or lactation Smokers or alcoholics Platelet dysfunction syndrome or thrombocytopenia Coagulation defects Uncontrolled diabetes Medical contraindications to elective oral surgery procedures Severe immunodeficiencies Oncological history Prosthetic restorations adjacent to gingival recessions Mobility II or III Occlusal contacts excessive Root caries Buccal restaurations Class V

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Interventional Model Description: Randomized clinical trial (RCT) (Interventional)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental side<br>Roots covered with coronally advanced flap (CAF) and platelet rich fibrin (PRF) (CAF+PRF) | Other: Platelet rich fibrin<br>* The roots of patients with diagnosis of gingival recessions will be covered with coronally advanced flap (CAF) and platelet rich fibrin (PRF) (CAF+PRF)<br>|
| Active Comparator: Control side<br>Roots covered with coronally advanced flap (CAR) | Other: Platelet rich fibrin<br>* The roots of patients with diagnosis of gingival recessions will be covered with coronally advanced flap (CAF) and platelet rich fibrin (PRF) (CAF+PRF)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of percentage of root coverage (PRC) from baseline at 12 and 24 months | Complete root coverage after surgical correction measured in percentage by using periodontal probe. PRC= Preoperative recession depth - Postoperative recession depth X 100 % Preoperative recession depth | baseline, 1, 3 , 6, 9, 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertical gingival recession (VGR) | It is measuring the distance from the cemento-enamel junction (CEJ) to the margin of the gingiva at the midbuccal point of the teeth (measured using a periodontal probe in millimeters). | baseline, 1, 3 , 6, 9, 12 and 24 months | 
| Horizontal gingival recession (HGR) | Measured horizontally between two borders of the recession. (measured using a periodontal probe in millimeters). | baseline, 1, 3 , 6, 9, 12 and 24 months | 
| Probing depth (PD) | It is measuring the distance from the gingival margin to the base of the pocket using periodontal probe. The probe will be inserted parallel to the long axis of the tooth using light force. (measured using a periodontal probe in millimeters). | baseline, 1, 3 , 6, 9, 12 and 24 months | 
| Clinical attachment level(CAL) | Two measurements will be used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. | baseline, 1, 3 , 6, 9, 12 and 24 months | 
| Gingival tissue thickness | The gingiva mid-buccally in the attached gingiva will be penetrated with an endodontic reamer with a silicon disc stop. The measure of penetration will be measured with dentimeter (mm). | baseline, 1, 3 , 6, 9, 12 and 24 months | 
| Keratinized tissue height (KTH) | To measure the tissue thickness, a guiding device will be made to standardize the region to be measured and then, at a specific point, the mucosa will be punctured with an endodontic spacer and the thickness marked with a rubber marker. Then, using a digital caliper, the thickness will be measured. | baseline, 1, 3 , 6, 9, 12 and 24 months | 
| Gingival bleeding index (IS) | Evaluation of the presence and absence of bleeding in the gingival margin through the gingival sulcus. The index is calculated after penetration of the sulcus by the periodontal probe, bleeding surfaces are noted and then counted. The index is calculated by dividing the number of surfaces that bleed by the total number of teeth and then multiplying by 100 to reach the percentage of bleeding index. | baseline, 1, 3 , 6, 9, 12 and 24 months | 
| Visual analog scale (VAS) | Visual analog scale | baseline, 1, 3 , 6, 9, 12 and 24 months | 
| Evaluation of oral health impact on quality of life, using the Oral Health Impact Profile (OHIP-14) questionnaire. | Evaluate the impact of oral health on patient's quality of life before and 1 year after implant installation. This evaluation will be carried out through the application of a questionnaire with 14 questions (Oral Health Impact Profile: OHIP-14) that assess the patient's perception regarding the impact of oral conditions on their well-being | baseline, 1, 3 , 6, 9, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet-rich fibrin, platelet concentrates, periodontal diseases