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Two Techniques for Root Coverage With a Xenogeneic Collagen Matrix

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ClinicalTrials.gov Identifier: NCT02129504
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : May 2, 2014
Sponsor:
Information provided by (Responsible Party):
Arthur Belem Novaes Jr, University of Sao Paulo

Brief Summary:
Gingival recessions are often successfully treated by coronally advanced flap technique (CAF) associated with subepithelial connective tissue grafts (SCTG). Currently the xenogeneic collagen matrix (CM) has been used as a substitute for SCTG associated with CAF technique for root coverage. CAF technique was not developed for use with CM and has shown limited results when applied to the CM. The aim of this study was to compare and show the benefits of the extended flap technique (EFT) compared to CAF technique using CM for root coverage.

Condition or disease Intervention/treatment Phase
Gingival Recession Device: root coverage comparing two techniques Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Surgical Techniques to Optimize the Treatment of Gingival Recessions Using a Gingival Graft Substitute.
Study Start Date : September 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: coronal advanced technique
root coverage with the porcine collagen matrix using the coronal advanced technique (standard technique)
Device: root coverage comparing two techniques
The aim of this study was to compare and show the benefits of the extended flap technique (new technique) compared to coronal advanced technique (gold standard technique) both techniques using the porcine collagen matrix for root coverage.
Other Names:
  • Mucograft
  • porcine collagen matrix
  • extended flap technique
  • coronal advanced flap technique

Experimental: extended flap technique
root coverage with the porcine collagen matrix using the extended flap technique (new surgical technique)
Device: root coverage comparing two techniques
The aim of this study was to compare and show the benefits of the extended flap technique (new technique) compared to coronal advanced technique (gold standard technique) both techniques using the porcine collagen matrix for root coverage.
Other Names:
  • Mucograft
  • porcine collagen matrix
  • extended flap technique
  • coronal advanced flap technique




Primary Outcome Measures :
  1. Comparing changes for Root coverage measure (in millimeter) from baseline at 3, 6 and 12 months [ Time Frame: Change from Baseline at 3, 6 and 12 months ]
    At the mid-buccal point of the involved tooth, the gingival recession height was measure by the same operator, who was previously calibrated (intra-examiner calibration) using a digital paquimeter.



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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ages 25 to 50 years old
  • bilateral gingival recession type Miller class I or II
  • with 3 mm in height and less than 3mm of keratinized tissue
  • non-molar teeth

Exclusion Criteria:

  • diabetics
  • pregnant women
  • chronic use of medication
  • periodontitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129504


Locations
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Brazil
School of dentistry of Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil, 14040-904
Sponsors and Collaborators
University of Sao Paulo

Publications:
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Responsible Party: Arthur Belem Novaes Jr, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02129504     History of Changes
Other Study ID Numbers: PCM
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: May 2014

Keywords provided by Arthur Belem Novaes Jr, University of Sao Paulo:
root coverage
gingival recession
periodontal surgery

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