Acellular Dermal Matrix Allograft Versus Free Gingival Graft

Not Applicable

Completed

• Conditions: Gingivitis; Gingiva Atrophy
• Interventions: Device: Acellular Dermal Matrix; Procedure: Control

• Registration Number: NCT03251001
• Lead Sponsor: University of Sao Paulo

Brief Summary

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)

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 1999-02-01
• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-16
• Primary Completion: 2017-11-30
• Study Completion: 2017-12-20
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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%)

Read More

Exclusion Criteria

• Allergic to penicillin
• Presenting systemic disease that impede surgical procedure
• Smokers
• Pregnancy
• Intake of calcium channel blockers that cause gingival augmentation

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device - Acellular dermal matrix	Acellular Dermal Matrix	Sites receiving acellular dermal matrix
Control	Control	Sites receiving a free gingival graft

Primary Outcome Measures

Name	Time	Method
keratinized tissue width	18 years	Distance from gingival margin to mucogingival junction, measured with a periodontal probe in mm. Ideal if mucosa width is \> 5mm.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bauru School of Dentistry; 🇧🇷 Bauru, Sao Paulo, Brazil