Xenogenous Collagen Matrix Graft With or Without Enamel Matrix Proteins Derivative for Root Coverage

University of Campinas, Brazil

Status and phase: Completed; Phase 4

Conditions: Gingival Recession

Treatments: Device: Emdogain; Device: Mucograft; Procedure: Coronally Advanced flap

Study type: Interventional

Funder types: Other

Identifiers

NCT02456337

067/2013

2013/19473-6 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the reduction of gingival recession of single Miller Class I and II defects treated by coronally advanced flap with subepithelial porcine collagen matrix graft and / or enamel matrix proteins.

Enrollment: 49 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• Presence of at least one Class I or II Miller gingival recession ≥ 2.5 mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ) and without deep non-carious cervical lesions (< 0.5 mm): A +(Pini-Prato et al. 2010).
• Aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus.
• Full-mouth visible plaque index ≤ 20% (Ainamo & Bay 1975).
• Full-mouth sulcus bleeding index ≤ 20% (Mühlemann & Son 1971).

Exclusion criteria

• Smoking.
• Pregnancy.
• Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery).
• Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair).
• Previous periodontal surgery in the area.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 4 patient groups

CAF+MC+EMD

Experimental group

Description:

Coronally Advanced Flap with Mucograft and Emdogain

Treatment:

Device: Emdogain

Procedure: Coronally Advanced flap

Device: Mucograft

CAF+MC

Active Comparator group

Description:

Coronally Advanced Flap with Mucograft

Treatment:

Procedure: Coronally Advanced flap

Device: Mucograft

CAF+EMD

Active Comparator group

Description:

Coronally Advanced Flap with Emdogain

Treatment:

Device: Emdogain

Procedure: Coronally Advanced flap

CAF

Active Comparator group

Description:

Coronally Advanced Flap alone

Treatment:

Procedure: Coronally Advanced flap