Coronally Advanced Flap With or Without Porcine Collagen Matrix for Root Coverage

Enilson Antonio Sallum

Status and phase: Completed; Phase 4

Conditions: Gingival Recession

Treatments: Device: Mucograft; Procedure: Coronally Advanced Flap

Study type: Interventional

Funder types: Other

Identifiers

NCT02242500

130/2010

Details and patient eligibility

About

The purpose of this study is to compare the clinical outcomes after coronally advanced flap technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment of single gingival recessions. For this blinded randomized controlled clinical trial, 40 patients with Miller Class I or II gingival recession ≥ 2 mm in canines or premolars will selected and randomly assigned to receive either CAF or CAF+CM. The clinical parameters evaluated will be probing depth, clinical attachment level, gingival recession height, height and thickness of keratinized tissue. Clinical measurements will be taken at baseline and 45 days, 2, 3 and 6 months after surgery.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• Presence of at least one Class I or II Miller gingival recession ≥ 2 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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40 participants in 2 patient groups

Coronally advanced flap + Mucograft

Experimental group

Description:

coronally advanced flap associated with a porcine collagen matrix graft as a subepithelial graft

Treatment:

Procedure: Coronally Advanced Flap

Device: Mucograft

Coronally advanced flap

Other group

Description:

Coronally advanced flap procedure alone

Treatment:

Procedure: Coronally Advanced Flap