Acellular Dermal Matrix Allograft Versus Free Gingival Graft

Study Overview
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Brief Summary
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The present split-mouth controlled randomized clinical trial aimed to evaluate clinical and histological results of acellular dermal matrix allograft (ADM) compared to autogenous free gingival graft (FGG)

Official Title
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Acellular Dermal Matrix Allograft Versus Free Gingival Graft: a Histological Evaluation and Split-mouth Randomized Clinical Trial

Conditions
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Gingivitis, Gingiva Atrophy

Intervention / Treatment
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* Procedure: Control
* Device: Acellular Dermal Matrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: absence or deficiency of keratinized tissue (< 1mm) in two homologous contralateral sites of inferior premolars Miller Class I or II gingival recession Absence of radiographic bone loss Vital tooth or with adequate endodontic treatment Root surfaces without caries Good oral hygiene (plaque index < 20%) Exclusion Criteria: Allergic to penicillin Presenting systemic disease that impede surgical procedure Smokers Pregnancy Intake of calcium channel blockers that cause gingival augmentation

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: Split-mouth design. One side of mouth was test group, other side was control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Sites receiving a free gingival graft | Procedure: Control<br>* Free epithelized gingival graft, harvested from palate, was grafted in a site with lack of keratinized gingiva<br>|
| Experimental: Device - Acellular dermal matrix<br>Sites receiving acellular dermal matrix | Device: Acellular Dermal Matrix<br>* Acellular Dermal Matrix was grafted in a site with lack of keratinized gingiva, in substitution of an autogenous graft from patient palate<br>* Other names: allograft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| keratinized tissue width | Distance from gingival margin to mucogingival junction, measured with a periodontal probe in mm. Ideal if mucosa width is > 5mm. | 18 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | Distance from gingival margin to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm. | 18 years | 
| Attachment level | Distance from cemento-enamel junction to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm. | 18 years | 
| Recession depth | Distance from cemento-enamel junction to gingival margin, measured with a periodontal probe. Ideal if = 0mm. | 18 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gingiva, keratinized mucosa, gingival graft