A New Therapeutic Approach for Root Coverage

Gingival Recession Clinical Trial

Official title:

A New Regenerative Therapeutic Approach for Root Coverage: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143610
• Other study ID #: 115-2007
• Status: Completed
• Phase: N/A
• First received: April 30, 2010
• Last updated: June 18, 2012
• Start date: February 2008
• Est. completion date: February 2009

Study information

• Verified date: June 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Newly forming bone technique for root coverage
A granulation tissue will be obtained 21-25 days after the creation of an alveolar socket and grafted to receptor site.

Other:
• Subepithelial connective tissue graft for root coverage.
A subepithelial connective tissue graft will be used for the treatment of Miller class I or II deep recessions.

Locations

Country	Name	City	State
Brazil	School of Dentistry at Bauru-USP, Discipline of Periodontics	Bauru	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Root Coverage	Percentage of root coverage determined by: [area covered]/[total area to be covered] x 100 (in %)	Baseline, 9 months post-operatively	No
Secondary	Gain of Clinical Attachment Level	Investigation of clinical attachment level, probing depth and reduction of recession depth	9 months post-operatively	No

External Links

•   School of Dentistry at Bauru, University of São Paulo site information