Gingival Recession
Conditions
Keywords
Root coverage, Graft, Soft tissue, Periodontal regeneration
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.
Interventions
PROCEDURENewly 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.
OTHERSubepithelial 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.
Sponsors
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Root Coverage | Baseline, 9 months post-operatively | Percentage of root coverage determined by: \[area covered\]/\[total area to be covered\] x 100 (in %) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gain of Clinical Attachment Level | 9 months post-operatively | Investigation of clinical attachment level, probing depth and reduction of recession depth |
Countries
Brazil
Participant flow
Recruitment details
Patients both genders, 18-45 years, showing at least one site with gingival recession should attend the Graduation Clinics of Periodontics, School of Dentistry at Bauru-USP, from October to December 2007 for enrollment in a new treatment protocol.
Pre-assignment details
Participants were excluded from the study prior to group assignement in cases of pregnancy, diagnosis of systemic disease or if the patient quit participating.
Participants by arm
| Arm | Count |
|---|---|
| Newly Forming Bone Miller class I or II deep recessions treated by the newly forming bone technique. | 7 |
| Subepithelial Connective Tissue Graft Miller class I or II deep recessions treated by subepithelial connective tissue graft. | 8 |
| Total | 15 |
Baseline characteristics
| Characteristic | Subepithelial Connective Tissue Graft | Newly Forming Bone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 7 Participants | 15 Participants |
| Age Continuous | 41.5 years STANDARD_DEVIATION 2.67 | 41 years STANDARD_DEVIATION 4.24 | 41.26 years STANDARD_DEVIATION 3.39 |
| Region of Enrollment Brazil | 8 participants | 7 participants | 15 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 |
Outcome results
Primary
Percentage of Root Coverage
Percentage of root coverage determined by: \[area covered\]/\[total area to be covered\] x 100 (in %)
Time frame: Baseline, 9 months post-operatively
Population: The unity of analysis was the site, since each participant contributed with more than one site for treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Newly Forming Bone | Percentage of Root Coverage | 66 percentage of area covered |
| Subepithelial Connective Tissue Graft | Percentage of Root Coverage | 73 percentage of area covered |
Secondary
Gain of Clinical Attachment Level
Investigation of clinical attachment level, probing depth and reduction of recession depth
Time frame: 9 months post-operatively
Population: The unit of analysis was the site, since each participant contributed with more than one site to be treated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Newly Forming Bone | Gain of Clinical Attachment Level | 3.74 mm | Standard Deviation 0.26 |
| Subepithelial Connective Tissue Graft | Gain of Clinical Attachment Level | 2.95 mm | Standard Deviation 0.19 |