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A New Therapeutic Approach for Root Coverage

NCT ID: NCT01143610

Last Updated: 2012-07-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-02-28

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.

Conditions

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Gingival Recession

Keywords

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Root coverage Graft Soft tissue Periodontal regeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Newly forming bone

Miller class I or II deep recessions treated by the newly forming bone technique.

Group Type EXPERIMENTAL

Newly forming bone technique for root coverage

Intervention Type PROCEDURE

A granulation tissue will be obtained 21-25 days after the creation of an alveolar socket and grafted to receptor site.

Subepithelial connective tissue graft

Miller class I or II deep recessions treated by subepithelial connective tissue graft.

Group Type ACTIVE_COMPARATOR

Subepithelial connective tissue graft for root coverage.

Intervention Type OTHER

A subepithelial connective tissue graft will be used for the treatment of Miller class I or II deep recessions.

Interventions

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Newly 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.

Intervention Type PROCEDURE

Subepithelial 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.

Intervention Type OTHER

Other Intervention Names

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Bone granulation NFBG SCTG

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Adriana Campos Passanezi SantAna

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adriana P Sant'Ana, DDS PhD

Role: PRINCIPAL_INVESTIGATOR

School of Dentistry at Bauru, University of São Paulo

Bruna R Ferraz, DDS

Role: PRINCIPAL_INVESTIGATOR

School of Dentistry at Bauru, University of São Paulo

Locations

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School of Dentistry at Bauru-USP, Discipline of Periodontics

Bauru, São Paulo, Brazil

Site Status

Countries

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Brazil

Related Links

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http://www.fob.usp.br

School of Dentistry at Bauru, University of São Paulo site information

Other Identifiers

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115-2007

Identifier Type: -

Identifier Source: org_study_id