A New Therapeutic Approach for Root Coverage
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Newly forming bone technique for root coverage
Subepithelial connective tissue graft for root coverage.
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring Root coverage, Graft, Soft tissue, Periodontal regeneration
Eligibility 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)
Sites / Locations
- School of Dentistry at Bauru-USP, Discipline of Periodontics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Newly forming bone
Subepithelial connective tissue graft
Arm Description
Miller class I or II deep recessions treated by the newly forming bone technique.
Miller class I or II deep recessions treated by subepithelial connective tissue graft.
Outcomes
Primary Outcome Measures
Percentage of Root Coverage
Percentage of root coverage determined by: [area covered]/[total area to be covered] x 100 (in %)
Secondary Outcome Measures
Gain of Clinical Attachment Level
Investigation of clinical attachment level, probing depth and reduction of recession depth
Full Information
NCT ID
NCT01143610
First Posted
April 30, 2010
Last Updated
June 18, 2012
Sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
1. Study Identification
Unique Protocol Identification Number
NCT01143610
Brief Title
A New Therapeutic Approach for Root Coverage
Official Title
A New Regenerative Therapeutic Approach for Root Coverage: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Root coverage, Graft, Soft tissue, Periodontal regeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Newly forming bone
Arm Type
Experimental
Arm Description
Miller class I or II deep recessions treated by the newly forming bone technique.
Arm Title
Subepithelial connective tissue graft
Arm Type
Active Comparator
Arm Description
Miller class I or II deep recessions treated by subepithelial connective tissue graft.
Intervention Type
Procedure
Intervention Name(s)
Newly forming bone technique for root coverage
Other Intervention Name(s)
Bone granulation, NFBG
Intervention Description
A granulation tissue will be obtained 21-25 days after the creation of an alveolar socket and grafted to receptor site.
Intervention Type
Other
Intervention Name(s)
Subepithelial connective tissue graft for root coverage.
Other Intervention Name(s)
SCTG
Intervention Description
A subepithelial connective tissue graft will be used for the treatment of Miller class I or II deep recessions.
Primary Outcome Measure Information:
Title
Percentage of Root Coverage
Description
Percentage of root coverage determined by: [area covered]/[total area to be covered] x 100 (in %)
Time Frame
Baseline, 9 months post-operatively
Secondary Outcome Measure Information:
Title
Gain of Clinical Attachment Level
Description
Investigation of clinical attachment level, probing depth and reduction of recession depth
Time Frame
9 months post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana P Sant'Ana, DDS PhD
Organizational Affiliation
School of Dentistry at Bauru, University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruna R Ferraz, DDS
Organizational Affiliation
School of Dentistry at Bauru, University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry at Bauru-USP, Discipline of Periodontics
City
Bauru
State/Province
SP
ZIP/Postal Code
17012-912
Country
Brazil
12. IPD Sharing Statement
Links:
URL
http://www.fob.usp.br
Description
School of Dentistry at Bauru, University of São Paulo site information
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A New Therapeutic Approach for Root Coverage
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