Treatment of Gingival Recession Defects Using Platelet-Rich Fibrin With an Allogenic Dermal Matrix

Study Overview
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Brief Summary
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The study aims to test the non-inferiority of an Allogenic Dermal Matrix with Platelet-Rich Fibrin for treatment of gingival recessions in comparison to the Connective Tissue Graft.

Detailed Description
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Currently the Connective Tissue Graft (CTG) is referred to as the gold standard in terms of the grafting material for the treatment of gingival recession defects. This study test the non-inferiority of the Allogenic Dermal Matrix (ADM) with Platelet-Rich Fibrin (PRF) to that of the CTG, in terms of the amount of root coverage obtained after the procedure.

Official Title
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Treatment of Gingival Recession Defects Using Platelet-Rich Fibrin With an Allogenic Dermal Matrix, Compared to the Connective Tissue Graft: A Parallel-arm, Randomized, Controlled, Assessor-blind, Non-inferiority Clinical Trial

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Tunneled coronally advanced flap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Periodontally and systemically healthy adults Full-mouth plaque score and full-mouth bleeding score ≤ 20% Presence of at least one 3 mm or deeper gingival recession, with at least 1.5 mm of Keratinized tissue, and 1 mm of gingival thickness) requiring surgical intervention for root coverage No interproximal attachment/bone loss No prior experience of root coverage procedures within the last 1 year The patient must be able to perform good oral hygiene Exclusion Criteria: Contraindications for undergoing periodontal surgery Teeth with more than Grade II mobility, or furcation involvement of Class III Patients pregnant or attempting to get pregnant (self-reported), or nursing women Untreated/active periodontitis, or other untreated acute infections at the surgical site Untreated malignancies at the surgical site Persistence of uncorrected gingival trauma from traumatic toothbrushing Presence of severe tooth malposition, rotation or clinically significant super-eruption Self-reported current smoking more than 10 cigarettes/day or pipe or cigar smoking, or active tobacco chewing, or chronic vaping Patients with any known history of blood disorders or complications such as abnormal concentration of thrombin and factor XIII in plasma, or hemophilia Patients with significant co-morbidities, such as obesity, uncontrolled diabetes, immunosuppression, severe endocrine-induced bone diseases, signs of malnourishment, those receiving immunosuppressive therapy, poor tissue oxygenation or perfusion, and pre- or post-operative radiation Patients with known sensitivity to Polysorbate 20, Cefoxitin, Lincomycin, polymyxin B, Vancomycin

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Connective Tissue Graft<br>A connective tissue graft from the patient's palate will be used | Procedure: Tunneled coronally advanced flap<br>* Describes the flap design for both treatment arms<br>|
| Experimental: Allogenic Dermal Matrix with Platelet-Rich Fibrin<br>An allogenic dermal matrix with the patient's platelet-rich fibrin will be used | Procedure: Tunneled coronally advanced flap<br>* Describes the flap design for both treatment arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean root coverage (mRC) | Measured as a percentage of the total baseline recession defect that coverage was obtained at. | Assessed at 6 months | 
| Complete root coverage (CRC) | Measured as a percentage of total treated sites, that obtained a full coverage of the recession defect | Assessed at 6 months | 
| Keratinized tissue (KT) gain | Measured in mm | Assessed at 6 months | 
| Gingival thickness (GT) gain | Measured in mm | Assessed at 6 months | 
| Patient-reported outcomes (PROMs) | In terms of pain/discomfort at the palatal donor site or patient's arm. Measured using a scale from 0 (lowest) to 10 (highest). | Measured from the day of the procedure up to a maximum of 1 month | 
| Duration of surgical procedure | Including the length of surgical procedure, drawing of blood, and preparation of PRF, harvesting of the autogenous CTG. Measured in minutes. | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Professionally evaluated esthetic score | Assessed using the Root coverage Esthetic Score (RES) system (from 0 lowest, to 10 highest) | Assessed at 6 months | 
| Soft tissue volume changes over time | Assessed using 3D scanner imaging in the units of mm | Changes of from baseline (prior to treatment) compared with 3 and 6 months | 
| Soft tissue volume changes over time | Assessed using dental ultrasonography in the units of mm | Measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months | 
| Soft tissue blood flow changes over time | Assessed and quantified using dental ultrasonography | Measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months | 
| Patient-reported esthetics | Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest). | Measured at baseline and at 6 months, and compared between these time points to provide subjective esthetic results | 
| Patient-reported satisfaction | Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest). | Measured at 6 months to provide the satisfaction score in VAS scale | 
| Patient-reported post-operative pain as measured with a mobile application | Measured using a mobile application at the recession grafted site, the donor site on the palate, and the donor site for the venopuncture. | From the day of the procedure until 1 month after the surgical time point |