A New Therapeutic Approach for Root Coverage

This study has been completed.
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Adriana Campos Passanezi SantAna, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01143610
First received: April 30, 2010
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Gingival Recession
Procedure: Newly forming bone technique for root coverage
Other: Subepithelial connective tissue graft for root coverage.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A New Regenerative Therapeutic Approach for Root Coverage: a Randomized Clinical Trial

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Percentage of Root Coverage [ Time Frame: Baseline, 9 months post-operatively ] [ Designated as safety issue: No ]
    Percentage of root coverage determined by: [area covered]/[total area to be covered] x 100 (in %)


Secondary Outcome Measures:
  • Gain of Clinical Attachment Level [ Time Frame: 9 months post-operatively ] [ Designated as safety issue: No ]
    Investigation of clinical attachment level, probing depth and reduction of recession depth


Enrollment: 15
Study Start Date: February 2008
Study Completion Date: February 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Newly forming bone
Miller class I or II deep recessions treated by the newly forming bone technique.
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 Names:
  • Bone granulation
  • NFBG
Active Comparator: Subepithelial connective tissue graft
Miller class I or II deep recessions treated by subepithelial connective tissue graft.
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.
Other Name: SCTG

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143610

Locations
Brazil
School of Dentistry at Bauru-USP, Discipline of Periodontics
Bauru, SP, Brazil, 17012-912
Sponsors and Collaborators
University of Sao Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Principal Investigator: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Adriana Campos Passanezi SantAna, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01143610     History of Changes
Other Study ID Numbers: 115-2007
Study First Received: April 30, 2010
Results First Received: October 29, 2011
Last Updated: June 18, 2012
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Sao Paulo:
Root coverage
Graft
Soft tissue
Periodontal regeneration

Additional relevant MeSH terms:
Gingival Recession
Gingival Diseases
Mouth Diseases
Periodontal Atrophy
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 29, 2014