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Completed

NCT Number: NCT01143610

A New Therapeutic Approach for Root Coverage

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.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry at Bauru-USP, Discipline of Periodontics

Bauru, São Paulo, 17012-912, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Bone granulation, NFBG

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.

Other names: SCTG

Primary outcomes

  1. Percentage of Root Coverage

    Time frame: Baseline, 9 months post-operatively

    Percentage of root coverage determined by: [area covered]/[total area to be covered] x 100 (in %)

Secondary outcomes

  1. Gain of Clinical Attachment Level

    Time frame: 9 months post-operatively

    Investigation of clinical attachment level, probing depth and reduction of recession depth

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jun 14, 2010
Registry last updated
Jul 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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