A New Therapeutic Approach for Root Coverage

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: Newly forming bone technique for root coverage; Other: Subepithelial connective tissue graft for root coverage.

• Registration Number: NCT01143610
• Lead Sponsor: University of Sao Paulo

Brief Summary

Different surgical techniques have been proposed for root coverage, showing varying results especially in areas of deep recessions. The aim of this study is to evaluate the effectiveness of the newly forming bone technique (NFB)as an alternative treatment for Miller class I or II deep recessions, requiring regeneration of lost periodontal tissues. Sample should be comprised of patients aged 18-45 years, both genders, presenting at least one site with marginal tissue recession \>4mm. Patients will be randomly assigned to either one of the groups, based on treatment technique: newly forming bone (NFB) or subepithelial connective tissue graft (SCTG). Clinical examinations will be performed by a single blinded examiner at baseline, 1, 3, 6 and 9 months after surgery. Intra-group analysis will be performed by one way analysis of variance for repeated measures. Inter-group analysis will be performed by unpaired t-test for each of evaluation periods.

Detailed Description

Both gender patients presenting Miller class I or II recession defects \>4mm were selected. Patients were randomly assigned to treatment groups: newly forming bone graft (NFBG) or subepithelial connective tissue graft (SCT). Patients were treated in the period of February 2008 and March 2008 and monitored during 9 months.

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-11
• Study Completion: 2009-02
• Study First Submitted: 2010-04-30
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Results First Submitted: 2011-10-29
• Status Verified: 2012-06
• Results First Submitted QC: 2012-06-18
• Last Update Submitted: 2012-06-18
• Results First Posted: 2012-07-24
• Last Update Posted: 2012-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Healthy adults with at least one tooth presenting marginal tissue recession equal to or greater than 4mm in depth and one edentulous area or tooth to be extracted.

Exclusion Criteria

• Smokers
• Pregnants
• Use of anti-convulsants, anti-hypertensives, cyclosporine or hormones
• Use of antibiotics for the last 6 months
• Patients under treatment for medical conditions or presenting systemic disorders that would impair treatment results (e.g.: uncontrolled diabetes mellitus)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Newly forming bone	Newly forming bone technique for root coverage	Miller class I or II deep recessions treated by the newly forming bone technique.
Subepithelial connective tissue graft	Subepithelial connective tissue graft for root coverage.	Miller class I or II deep recessions treated by subepithelial connective tissue graft.

Primary Outcome Measures

Name	Time	Method
Percentage of Root Coverage	Baseline, 9 months post-operatively	Percentage of root coverage determined by: \[area covered\]/\[total area to be covered\] x 100 (in %)

Secondary Outcome Measures

Name	Time	Method
Gain of Clinical Attachment Level	9 months post-operatively	Investigation of clinical attachment level, probing depth and reduction of recession depth

Trial Locations

Locations (1)

School of Dentistry at Bauru-USP, Discipline of Periodontics; 🇧🇷 Bauru, SP, Brazil