A New Therapeutic Approach for Root Coverage
June 18, 2012 updated by: Adriana Campos Passanezi SantAna, University of Sao Paulo
A New Regenerative Therapeutic Approach for Root Coverage: a Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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SP
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Bauru, SP, Brazil, 17012-912
- School of Dentistry at Bauru-USP, Discipline of Periodontics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Newly forming bone
Miller class I or II deep recessions treated by the newly forming bone technique.
|
A granulation tissue will be obtained 21-25 days after the creation of an alveolar socket and grafted to receptor site.
Other Names:
|
|
ACTIVE_COMPARATOR: Subepithelial connective tissue graft
Miller class I or II deep recessions treated by subepithelial connective tissue graft.
|
A subepithelial connective tissue graft will be used for the treatment of Miller class I or II deep recessions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 %)
|
Baseline, 9 months post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gain of Clinical Attachment Level
Time Frame: 9 months post-operatively
|
Investigation of clinical attachment level, probing depth and reduction of recession depth
|
9 months post-operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (ACTUAL)
November 1, 2008
Study Completion (ACTUAL)
February 1, 2009
Study Registration Dates
First Submitted
April 30, 2010
First Submitted That Met QC Criteria
June 11, 2010
First Posted (ESTIMATE)
June 14, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
July 24, 2012
Last Update Submitted That Met QC Criteria
June 18, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 115-2007
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