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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-08-31

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.

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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.

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SCPF + EMD (TEST)

Semilunar coronally positioned flap with Enamel matrix derivative (Emdogain)

Group Type EXPERIMENTAL

Semilunar coronally positioned flap

Intervention Type PROCEDURE

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

Enamel matrix derivative (Emdogain)

Intervention Type DEVICE

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

SCPF (CONTROL)

Semilunar coronally positioned flap alone

Group Type ACTIVE_COMPARATOR

Semilunar coronally positioned flap

Intervention Type PROCEDURE

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

Interventions

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Semilunar coronally positioned flap

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

Intervention Type PROCEDURE

Enamel matrix derivative (Emdogain)

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

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No