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Microsurgical Versus Conventional Semilunar Coronally Advanced Flap

NCT02433899 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-05-05

No results posted yet for this study

Summary

BACKGROUND: The semilunar coronally repositioned flap (SLCRF) has been used for the treatment of recession defects (GR). Recently a microsusgical (MICRO) has been successfully employed with the procedure apparently resulting in improved results, however, no previous controlled clinical study has evaluated the MICRO SLCRF in comparison with SLCRF performed as originally described (MACRO). The objective of the present study was to compare the clinical outcomes of the MICRO and MACRO SLCRF in the treatment of human GR.

METHODS: Fourteen patients, with bilateral Miller class I GR defects were randomly assigned to MICRO or MACRO SLCRF. Clinical parameters, assessed at baseline and 6 months later, included recession height (RECH), recession width (RECW), width of keratinized tissue (WKT), probing depth (PD), clinical attachment level (CAL), pain measurements and esthetic evaluation with the Root Coverage Score (RCS). Inter-measurements differences were analyzed with a Chi-square or a paired t-test, with significance set at α\<0.05.

Conditions

  • Gingival Recession

Interventions

PROCEDURE

MICROSURGERY

Semilunar coronally repositioned flap performed under magnification with a surgical microscope

PROCEDURE

MACROSURGERY

Semilunar coronally repositioned flap performed without magnification

DRUG

Dexamethasone

8mg Dexamethasone, single dose, 1 hour before surgery

DRUG

Chlorhexidine gluconate

Oral rinses with chlorhexidine gluconate, BID, for 14 days

DRUG

2.0% Mepivacaine + 1:100.000 epinephrine

Regional block

Sponsors & Collaborators

  • Universidade Federal Fluminense

    lead OTHER

Principal Investigators

  • Ronaldo B Santana, DDS,MScD,DSc · Federal Fluminense University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-04-30
Completion
2012-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02433899 on ClinicalTrials.gov