CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Open-flap +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01821157
NCT01821157N/ACompleted

Open-flap Versus Flapless Esthetic Crown Lengthening: 12-month Clinical Outcomes of a Randomized Controlled Clinical Trial

University of Guarulhos·interventional·Posted Mar 29, 2013·Updated Apr 2, 2013

In Brief

A clinical study evaluating Open-flap and Flapless for Gingival Overgrowth. Completed, enrolled 28 participants across 1 site.

Detailed Summary

The aim of this study is to compare the clinical outcomes of open-flap (OF) and flapless (FL) esthetic crown lengthening (ECL) for the treatment of excessive gingival display (EGD). It was hypothesized that the FL surgery would yield similar clinical results to the OF technique up to 12 months. Methods: A split-mouth randomized controlled trial will be conducted in 28 subjects presenting EGD. Contralateral quadrants will receive ECL using OF or FL techniques. Clinical parameters will be evaluated at baseline, 3, 6 and 12 months post-surgeries. The local levels of receptor activator of NF-КB ligand (RANKL) and osteoprotegerin (OPG) will be assessed by ELISA at baseline and 3 months. Patients' perceptions regarding morbidity and esthetical appearance will be also evaluated. Periodontal tissue dimensions will be obtained by computed tomography at baseline and correlated with the changes in the gingival margin (GM).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2013
Enrollment StartJan 1, 2011
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.3 years ago

Interventions

Open-flapprocedure

Open-flap(control group; n=28 sides/105 teeth): An internal beveled incision was performed at the buccal aspect of the involved teeth. Afterwards, a sulcular incision was completed to allow gingival tissue removal. A full-thickness mucoperiosteal flap was reflected to remove and remodel bone tissue by means of surgical chisels, as necessary, until a 3mm distance was achieved between the bone crest and the cement-enamel junction (CEJ). The exposed root surfaces were carefully planed with curettes. Interrupted sutures were performed at the papilla to allow GM stabilization in the CEJ position.

Flaplessprocedure

FL (test group; n=28 sides/105 teeth): Internal beveled and sulcular incisions and gingival tissue removal were performed as above described for the control group, replacing the GM in the CEJ position. However, the alveolar bone was removed and remodeled, as necessary, using micro chisels, via incisions, without flap elevation. The root surfaces were also carefully planed via incisions. The required distance of 3mm between the bone crest and the CEJ was checked by inserting a periodontal probe into the incision. Sutures were not performed.