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Clinical Comparison Between Two Surgical Techniques for the Treatment of Gingival Recessions

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Arthur Belem Novaes Jr, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01175720
First received: August 3, 2010
Last updated: November 11, 2011
Last verified: November 2011
  Purpose

The aim of this study is to test a surgical technique for the treatment of gingival recessions. The hypothesis of the study is to promote greater root coverage and better healing.


Condition Intervention
Gingival Recession
Procedure: Periodontal surgery to gingival recessions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Comparison Between Two Surgical Techniques With Acellular Dermal Matrix Graft in the Treatment of Gingival Recessions

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Percentage of root coverage [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinical parameters will be assessed after 6 months of surgical procedures.


Secondary Outcome Measures:
  • Keratinized Tissue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinical parameters will be assessed after 6 months of surgical procedures.


Enrollment: 15
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: test and control
The test and control technique will be tested in a split-mouth design.
Procedure: Periodontal surgery to gingival recessions
Test and control technique to treat gingival recessions.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Recession defects are Miller's class I or II and do not vary more or equal than 3 mm
  • Main complaint aesthetic issues or dentine hypersensitivity
  • The patient must be a candidate for bilateral root coverage procedure
  • Patient shows sufficient plaque control (FMPS < 20%)
  • The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
  • The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent

Exclusion Criteria:

  • Smokers
  • Systemic diseases
  • Pregnants or lactating
  • Periodontal disease
  • General contraindications for dental and/or surgical treatment are present
  • The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
  • The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175720

Locations
Brazil
Faculty of Dentistry of Ribeirão Preto USP
Ribeirão Preto, São Paulo, Brazil, 14040-904
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Arthur B. Novaes Júnior, PhD University of Sao Paulo
Principal Investigator: Lauro G. Ayub, MSD student University of Sao Paulo
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arthur Belem Novaes Jr, Clinical comparison between two surgical techniques with acellular dermal matrix graft in the treatment of gingival recessions, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01175720     History of Changes
Other Study ID Numbers: lga030183
Study First Received: August 3, 2010
Last Updated: November 11, 2011
Health Authority: Brazil: University of Sao Paulo
Brazil: Faculty of Dentistry of Ribeirão Preto

Keywords provided by University of Sao Paulo:
gingival recession
acellular dermal matrix graft
root coverage

Additional relevant MeSH terms:
Gingival Recession
Gingival Diseases
Mouth Diseases
Periodontal Atrophy
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 20, 2014