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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459704
• Other study ID #: 038/2012
• Secondary ID: 2013/13098-9
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2015
• Last updated: October 6, 2015
• Start date: June 2014
• Est. completion date: August 2015

Study information

• Verified date: May 2015
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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

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

Locations

Country	Name	City	State
Brazil	Piracicaba Dental School, State University of Campinas	Piracicaba	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Complete root coverage	Assessed as percentage of sites with complete root coverage	12 months	No