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A New Therapeutic Approach for Root Coverage

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01143610
First Posted: June 14, 2010
Last Update Posted: July 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Adriana Campos Passanezi SantAna, University of Sao Paulo
  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
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A New Regenerative Therapeutic Approach for Root Coverage: a Randomized Clinical Trial

Further study details as provided by Adriana Campos Passanezi SantAna, University of Sao Paulo:

Primary Outcome Measures:
  • Percentage of Root Coverage [ Time Frame: Baseline, 9 months post-operatively ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: April 30, 2010
First Posted: June 14, 2010
Results First Submitted: October 29, 2011
Results First Posted: July 24, 2012
Last Update Posted: July 24, 2012
Last Verified: June 2012

Keywords provided by Adriana Campos Passanezi SantAna, University of Sao Paulo:
Root coverage
Graft
Soft tissue
Periodontal regeneration

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