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OpenTrials
Completed

NCT Number: NCT02129504

Two Techniques for Root Coverage With a Xenogeneic Collagen Matrix

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.

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Key information

Conditions

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

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of dentistry of Ribeirão Preto

Ribeirão Preto, São Paulo, 14040-904, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

root coverage comparing two techniques

Device

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Comparison of Two Surgical Techniques to Optimize the Treatment of Gingival Recessions Using a Gingival Graft Substitute.

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 2, 2014
Registry last updated
May 2, 2014

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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