Injectable Platelet Rich Fibrin With Collagen Matrix in Treatment of Multiple Gingival Recession.

Study Overview
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Brief Summary
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This study is proposing the use of i-PRF clot as a scaffold for the XCM in order to obtain a novel biomaterial, incorporating active growth factors and collagen matrix in a single framework, based on the potential effect of i-PRF to enhance fibroblast activity and angiogenesis stimulation for treatment of multiple gingival recession.

Official Title
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The Value of Injectable Platelet Rich Fibrin With Volume Stable Collagen Matrix in Treatment of Multiple Gingival Recession; a Randomized Clinical Trial.

Conditions
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Gingival Diseases, Traumatic Injury

Intervention / Treatment
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* Procedure: CAF+CM
* Procedure: I-PRF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of at least two localized gingival recessions on either sides of the maxilla and/or mandible excluding molar region. The cemento-enamel junction (CEJ) is visible in the teeth for root coverage procedures. All recessions are type 1recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession All patients must demonstrate adequate plaque control with a fullmouth plaque score less than 20% and with . All patients at least 18 years of age and of both genders. Exclusion Criteria: Smoker Patients . Patients with diabetes. Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy. pregnant or nursing women. Patients taking medications or having treatments with an effect on mucosal healing in general (e.g. steroids, large doses of antiinflammatory drugs). Patients with a disease affecting connective tissue metabolism. Patients allergic to collagen.

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control arm<br>Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession. | Procedure: CAF+CM<br>* Periodontal surgery including CAF+CM application<br>|
| Other: Experimental arm<br>Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I&II gingival recession. | Procedure: CAF+CM<br>* Periodontal surgery including CAF+CM application<br>Procedure: I-PRF<br>* Periodontal surgery including CAF+CM application with i-PRF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in gingival recession depth on the buccal sides of type one gingival recessionRT1 | The primary outcome of the study is the reduction in gingival recession depth on the buccal sides of RT1 gingival recession, between the baseline preoperative measurement and follow-up at 3 months and 6 months. The Recession Depth (RD) is Measured in millimeter (mm) from CEJ (Cemento-Enamel-Junction) to the gingival margin using UNC-15 probe. | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Gingival Thickness (GT) | Gingival Thickness (GT) is determined at 1.5 mm apical to the gingival margin using a caliper (endodontic reamer#20) rounded to the nearest 0.1mm. | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | 
| Improvement in the Keratinized Tissue Height (KTH) | Keratinized Tissue Height (KTH) is measured in millimeters (mm) taken at the mid buccal aspect of the involved teeth from the gingival margin to the muco-gingival junction, by a manual periodontal probe (UNC-15 probe,Hu-Friedy,Chicago,USA). | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | 
| Reduction in the Recession Width (RW) | Recession Width (RW) is measured in millimeter (mm) at the Cement-Enamel Junction (CEJ) using UNC-15 probe. | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | 
| Reduction in Probing Pocket Depth (PPD) | Probing Pocket Depth (PPD) is measured in millimeter (mm) from the gingival margin to the apical extend of the probe. | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | 
| Reduction Clinical Attachment Level (CAL) | Clinical Attachment Level (CAL) is measured in millimeter (mm) from the CEJ to the apical extend of the probe. | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | 
| Measuring Plaque-Index (PI) | Plaque-Index (PI) is measured as a percentage of the presence of Plaque on four surfaces of the teeth using a manual periodontal probe. | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | 
| Measuring Bleeding On Probing (BOP) | Bleeding On Probing (BOP) is measured as a percentage of sites with bleeding on probing using a manual periodontal probe. | Between the baseline preoperative measurement and follow-up at 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingival Recession, Collagen Matrix, Plasma rich proten