Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions A Multicenter Randomized Clinical Trial.

Study Overview
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Brief Summary
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Aim: The aim of this randomized clinical trial is to evaluate the use of the porcine acellular dermal matrix (PADM) for the treatment of RT1 localized gingival recessions. Material and methods: Forthy patients (n=20) with RT1 localized gingival recessions with height ranging from 3 to 5 mm with and at least, 2mm of keratinized tissue width will be selected to participate in the study. Patients will be allocated randomly in two treatment groups: Coronally advanced flap (CAF) or coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM). The clinical parameters evaluated at the baseline, 6 and 12 months will be: Plaque index (IPL); gingival index (GI); relative gingival recession height (RGRH); gingival recession width (GRW); probing depth (PD); relative clinical attachment level (RCAL); keratinized tissue height (KTH); keratinized tissue thickness (KTT); papilla height (PH). Evaluations will be made by the professional and the patient regarding dentin hypersensitivity (HD) (Schiff and VAS scales respectively), aesthetics (RES and VAS scales, respectively) and patient&#39;s centered outcomes, through the questionnaire referring to the OHIP-14. Descriptive statistical analysis will be expressed as mean ± standard deviation (SD), median, quartiles, percentages and confidence intervals (95% CI). To analyze the normality of the residue, the Shapiro-Wilk test will be performed. Then, the Wilcoxon test will be applied to compare the periodontal parameters and a quality of life, before and post-treatment. Correlations between parameters and dental hypersensitivity will be analyzed through Spearman&#39;s test. Key words: Gingival recession, Root coverage, Biomaterial, Acellular dermal matrix.

Official Title
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Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions: A Multicenter Randomized Clinical Trial

Conditions
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Gingival Recession

Intervention / Treatment
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* Device: Porcine acellular dermal matrix
* Other: Coronally advanced flap (CAF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: RT1 localized gingival recessions with height ranging from 3 to 5 mm with and at least, 2mm of keratinized tissue width will be selected to participate in the study; probing depth <3mm, plaque and gingival index < or = a 20%. Exclusion Criteria: Smokers, pregnants, nursing, patients with diabetes mellitus or another condition who interfere in the tissue repair, use of drugs or medications, allergies to any composition of the devices of the study.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coronally advanced flap (CAF)<br> | Other: Coronally advanced flap (CAF)<br>* Coronally advanced flap for root coverage<br>|
| Experimental: Coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM)<br> | Device: Porcine acellular dermal matrix<br>* Coronally advanced flap associated with the porcine acellular dermal matrix for root coverage<br>* Other names: Mucoderm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recession reduction | Reduction of the gingival recession height | Baseline, 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of keratinized tissue | Thickness of keratinized tissue evaluation after periodontal plastic surgery | Baseline, 6 months and 12 months |