A New Therapeutic Approach for Root Coverage

Study Overview
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Brief Summary
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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
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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.

Official Title
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A New Regenerative Therapeutic Approach for Root Coverage: a Randomized Clinical Trial

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Newly forming bone technique for root coverage
* Other: Subepithelial connective tissue graft for root coverage.


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Newly forming bone<br>Miller class I or II deep recessions treated by the newly forming bone technique. | Procedure: Newly forming bone technique for root coverage<br>* A granulation tissue will be obtained 21-25 days after the creation of an alveolar socket and grafted to receptor site.<br>* Other names: NFBG;|
| Active Comparator: Subepithelial connective tissue graft<br>Miller class I or II deep recessions treated by subepithelial connective tissue graft. | Other: Subepithelial connective tissue graft for root coverage.<br>* A subepithelial connective tissue graft will be used for the treatment of Miller class I or II deep recessions.<br>* Other names: SCTG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gain of Clinical Attachment Level | Investigation of clinical attachment level, probing depth and reduction of recession depth | 9 months post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Root coverage, Graft, Soft tissue, Periodontal regeneration