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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Miller Class I Gingival Recessions: Randomized Clinical Trial

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Semilunar coronally positioned flap
* Device: Enamel matrix derivative (Emdogain)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCPF + EMD (TEST)<br>Semilunar coronally positioned flap with Enamel matrix derivative (Emdogain) | Procedure: Semilunar coronally positioned flap<br>* Semilunar coronally positioned flap with enamel matrix derivative (Emdogain) or alone.<br>Device: Enamel matrix derivative (Emdogain)<br>* Enamel matrix derivative associated to semilunar coronally positioned flap (SCPF + EMD - test group)<br>|
| Active Comparator: SCPF (CONTROL)<br>Semilunar coronally positioned flap alone | Procedure: Semilunar coronally positioned flap<br>* Semilunar coronally positioned flap with enamel matrix derivative (Emdogain) or alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Recession Reduction as measured by difference between gingival recession depth | Measured as a difference between gingival recession depth at baseline and gingival recession at 6 months follow-up. | Baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete root coverage | Assessed as percentage of sites with complete root coverage | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingival Recession, Semilunar flap, Enamel matrix derivative, Periodontal regeneration