Clinical trial NCT02459704: Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Gingival Recessions
Official title: Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Miller Class I Gingival Recessions: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingival Recession
Keywords: Gingival Recession
Semilunar flap
Enamel matrix derivative
Periodontal regeneration
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Recession Reduction as measured by difference between gingival recession depth
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Complete root coverage
timeFrame: 12 months
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School, State University of Campinas
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Enilson A Sallum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franca-Grohmann IL, Sangiorgio JPM, Bueno MR, Casarin RCV, Silverio KG, Nociti FH Jr, Casati MZ, Sallum EA. Does enamel matrix derivative application improve clinical outcomes after semilunar flap surgery? A randomized clinical trial. Clin Oral Investig. 2019 Feb;23(2):879-887. doi: 10.1007/s00784-018-2506-y. Epub 2018 Jun 12.