Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Gingival Recessions

University of Campinas, Brazil

Status and phase: Completed; Phase 4

Conditions: Gingival Recession

Treatments: Device: Enamel matrix derivative (Emdogain); Procedure: Semilunar coronally positioned flap

Study type: Interventional

Funder types: Other

Identifiers

NCT02459704

2013/13098-9 (Other Grant/Funding Number)

038/2012

Details and patient eligibility

About

The aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be assigned in two groups. Half of patients will receive EMD associated to SCPF, while the other half, will receive SCPF alone.

Full description

The aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be selected, randomized and allocated in two groups: test group (SCPF + EMD) and control group (SCPF). The subjects will should present buccal Miller class I gingival recessions with height greater than or equal to 2.0 mm and less than to 4.0 mm in maxillary canines or premolars. Clinical parameters will be evaluated: gingival recession height (GRH), gingival recession width(GRW), clinical attachment level (CAL), probing depth (PD), height (HKT) and thickness (TKT) of keratinized tissue and papillas height (HP) and width(LP), as well as plaque and gingival index. These data will be collected at baseline and 180 days after surgery.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years;
• Presence of at least one Miller Class I gingival recession ≥ 2 mm or ≤ 4mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ);
• Height of keratinized tissue ≥ 2 mm;
• 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: Double Blind

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30 participants in 2 patient groups

SCPF + EMD (TEST)

Experimental group

Description:

Semilunar coronally positioned flap with Enamel matrix derivative (Emdogain)

Treatment:

Procedure: Semilunar coronally positioned flap

Device: Enamel matrix derivative (Emdogain)

SCPF (CONTROL)

Active Comparator group

Description:

Semilunar coronally positioned flap alone

Treatment:

Procedure: Semilunar coronally positioned flap