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

University of Campinas, Brazil30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gingival Recession

Interventions

Semilunar coronally positioned flapPROCEDURE

Semilunar coronally positioned flap with enamel matrix derivative (Emdogain) or alone.

Enamel matrix derivative (Emdogain)DEVICE

Enamel matrix derivative associated to semilunar coronally positioned flap (SCPF + EMD - test group)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, Brazil

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 12 months

Secondary Outcomes

Complete root coverage

Assessed as percentage of sites with complete root coverage

Time frame: 12 months

Data from ClinicalTrials.gov

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