N/A
N=15
A New Therapeutic Approach for Root Coverage
Gingival Recession
Bottom Line
View on ClinicalTrials.gov: NCT01143610 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: Percentage of Root Coverage — 66; 73 percentage of area covered
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Newly forming bone technique for root coverage (Procedure); Subepithelial connective tissue graft for root coverage. (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Sao Paulo
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Root Coverage |
66; 73 | — |
| SECONDARY Gain of Clinical Attachment Level |
3.74; 2.95 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT01143610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.