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| Name | Class |
|---|---|
| Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newly forming bone | Experimental | Miller class I or II deep recessions treated by the newly forming bone technique. |
|
| Subepithelial connective tissue graft | Active Comparator | Miller class I or II deep recessions treated by subepithelial connective tissue graft. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Newly forming bone technique for root coverage | Procedure | A granulation tissue will be obtained 21-25 days after the creation of an alveolar socket and grafted to receptor site. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry at Bauru-USP, Discipline of Periodontics | Bauru | São Paulo | 17012-912 | Brazil |
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| Label | URL |
|---|---|
| School of Dentistry at Bauru, University of São Paulo site information | View source |
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Participants were excluded from the study prior to group assignement in cases of pregnancy, diagnosis of systemic disease or if the patient quit participating.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Newly Forming Bone | Miller class I or II deep recessions treated by the newly forming bone technique. |
| FG001 | Subepithelial Connective Tissue Graft | Miller class I or II deep recessions treated by subepithelial connective tissue graft. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Newly Forming Bone | Miller class I or II deep recessions treated by the newly forming bone technique. |
| BG001 | Subepithelial Connective Tissue Graft | Miller class I or II deep recessions treated by subepithelial connective tissue graft. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Root Coverage | Percentage of root coverage determined by: [area covered]/[total area to be covered] x 100 (in %) | The unity of analysis was the site, since each participant contributed with more than one site for treatment | Posted | Mean | Full Range | percentage of area covered | Baseline, 9 months post-operatively | sites | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Newly Forming Bone | Miller class I or II deep recessions treated by the newly forming bone technique. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adriana Campos Passanezi Sant'Ana | School of Dentistry at Bauru - USP | 00 55 14 3235-8278 | acpsantana@usp.br |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Subepithelial connective tissue graft for root coverage. | Other | A subepithelial connective tissue graft will be used for the treatment of Miller class I or II deep recessions. |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Gain of Clinical Attachment Level | Investigation of clinical attachment level, probing depth and reduction of recession depth | The unit of analysis was the site, since each participant contributed with more than one site to be treated | Posted | Mean | Standard Deviation | mm | 9 months post-operatively | sites | Participants |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Subepithelial Connective Tissue Graft | Miller class I or II deep recessions treated by subepithelial connective tissue graft. | 0 | 8 | 0 | 8 |
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| D055093 |
| Periodontal Atrophy |