Two Techniques for Root Coverage With a Xenogeneic Collagen Matrix

NCT02129504 | Completed DMC

• 1 other identifier: PCM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Keywords

root coverage; gingival recession; periodontal surgery

Outcome Measures

Primary Outcomes (1)

• Comparing changes for Root coverage measure (in millimeter) 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.

  Change from Baseline at 3, 6 and 12 months

Study Arms (2)

coronal advanced technique

EXPERIMENTAL

root coverage with the porcine collagen matrix using the coronal advanced technique (standard technique)

Device: root coverage comparing two techniques

extended flap technique

EXPERIMENTAL

root coverage with the porcine collagen matrix using the extended flap technique (new surgical technique)

Device: root coverage comparing two techniques

Interventions

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.

Also known as: Mucograft, porcine collagen matrix, extended flap technique, coronal advanced flap technique

coronal advanced technique; extended flap technique

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of dentistry of Ribeirão Preto

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Publications (1)

• McGuire MK, Scheyer ET. Xenogeneic collagen matrix with coronally advanced flap compared to connective tissue with coronally advanced flap for the treatment of dehiscence-type recession defects. J Periodontol. 2010 Aug;81(8):1108-17. doi: 10.1902/jop.2010.090698.

  PMID: 20350159 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 2, 2014
• Study Start: September 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 2, 2014

Record last verified: 2014-05

Locations

BR (1)