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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 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 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.
Sponsor: University of Campinas, Brazil

Current Primary Outcome: Change in Recession Reduction as measured by difference between gingival recession depth [ Time Frame: Baseline, 12 months ]

Measured as a difference between gingival recession depth at baseline and gingival recession at 6 months follow-up.


Original Primary Outcome: Change in Recession Reduction as measured by difference between gingival recession depth [ Time Frame: Baseline, 6 months ]

Measured as a difference between gingival recession depth at baseline and gingival recession at 6 months follow-up.


Current Secondary Outcome: Complete root coverage [ Time Frame: 12 months ]

Assessed as percentage of sites with complete root coverage


Original Secondary Outcome: Complete root coverage [ Time Frame: 6 months ]

Assessed as percentage of sites with complete root coverage


Information By: University of Campinas, Brazil

Dates:
Date Received: May 25, 2015
Date Started: June 2014
Date Completion:
Last Updated: October 6, 2015
Last Verified: May 2015