A New Therapeutic Approach for Root Coverage

University of Sao Paulo

Status: Completed

Conditions: Gingival Recession

Treatments: Procedure: Newly forming bone technique for root coverage; Other: Subepithelial connective tissue graft for root coverage.

Study type: Interventional

Funder types: Other

Identifiers

NCT01143610

115-2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Newly forming bone

Experimental group

Description:

Miller class I or II deep recessions treated by the newly forming bone technique.

Treatment:

Procedure: Newly forming bone technique for root coverage

Subepithelial connective tissue graft

Active Comparator group

Description:

Miller class I or II deep recessions treated by subepithelial connective tissue graft.

Treatment:

Other: Subepithelial connective tissue graft for root coverage.