A New Therapeutic Approach for Root Coverage

NCT01143610 | Completed Results

• 1 other identifier: 115-2007
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Keywords

Root coverage; Graft; Soft tissue; Periodontal regeneration

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Gain of Clinical Attachment Level

  9 months post-operatively

Study Arms (2)

Newly forming bone

EXPERIMENTAL

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

Procedure: Newly forming bone technique for root coverage

Subepithelial connective tissue graft

ACTIVE COMPARATOR

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

Other: Subepithelial connective tissue graft for root coverage.

Interventions

Newly forming bone technique for root coverage PROCEDURE

A granulation tissue will be obtained 21-25 days after the creation of an alveolar socket and grafted to receptor site.

Also known as: Bone granulation, NFBG

Newly forming bone

Subepithelial connective tissue graft for root coverage. OTHER

A subepithelial connective tissue graft will be used for the treatment of Miller class I or II deep recessions.

Also known as: SCTG

Subepithelial connective tissue graft

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sao Paulo: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

School of Dentistry at Bauru-USP, Discipline of Periodontics

Bauru, São Paulo, 17012-912, Brazil

Location

Related Links

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

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Results Point of Contact

• Title: Adriana Campos Passanezi Sant'Ana
• Organization: School of Dentistry at Bauru - USP

acpsantana@usp.br

00 55 14 3235-8278

Study Officials

• Adriana P Sant'Ana, DDS PhD

  School of Dentistry at Bauru, University of São Paulo

  PRINCIPAL INVESTIGATOR

• Bruna R Ferraz, DDS

  School of Dentistry at Bauru, University of São Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: June 14, 2010
• Study Start: February 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: February 1, 2009
• Last Updated: July 24, 2012
• Results First Posted: July 24, 2012

Record last verified: 2012-06

Locations

BR (1)