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

Phase 4

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: Semilunar coronally positioned flap; Device: Enamel matrix derivative (Emdogain)

• Registration Number: NCT02459704
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-06
• Status Verified: 2015-05
• Study First Submitted: 2015-05-25
• Primary Completion: 2015-06
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-02
• Study Completion: 2015-08
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCPF + EMD (TEST)	Semilunar coronally positioned flap	Semilunar coronally positioned flap with Enamel matrix derivative (Emdogain)
SCPF + EMD (TEST)	Enamel matrix derivative (Emdogain)	Semilunar coronally positioned flap with Enamel matrix derivative (Emdogain)
SCPF (CONTROL)	Semilunar coronally positioned flap	Semilunar coronally positioned flap alone

Primary Outcome Measures

Name	Time	Method
Change in Recession Reduction as measured by difference between gingival recession depth	Baseline, 12 months	Measured as a difference between gingival recession depth at baseline and gingival recession at 6 months follow-up.

Secondary Outcome Measures

Name	Time	Method
Complete root coverage	12 months	Assessed as percentage of sites with complete root coverage

Trial Locations

Locations (1)

Piracicaba Dental School, State University of Campinas; 🇧🇷 Piracicaba, São Paulo, Brazil