Two Techniques for Root Coverage With a Xenogeneic Collagen Matrix

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129504
• Other study ID #: PCM
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: May 1, 2014
• Start date: September 2010
• Est. completion date: July 2013

Study information

• Verified date: May 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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.

Locations

Country	Name	City	State
Brazil	School of dentistry of Ribeirão Preto	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes