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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02459704

Enrollment

Registered

2015-06-02

Start date

2014-06-30

Completion date

2015-08-31

Last updated

2015-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

Keywords

Gingival Recession, Semilunar flap, Enamel matrix derivative, Periodontal regeneration

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.

Interventions

PROCEDURESemilunar coronally positioned flap

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

DEVICEEnamel matrix derivative (Emdogain)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Complete root coverage	12 months	Assessed as percentage of sites with complete root coverage

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026