Clinical Trial: Comparison of Root Coverage of Gingival Recessions

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Comparison of Root Coverage of Gingival Recessions Using Connective Tissue Graft and Collagen Matrix

Brief Summary: The purpose of this study is to analyze the percentage of root coverage in Miller class I and II gingival recessions using connective tissue graft and collagen matrix with a two years follow-up.

Detailed Summary:

A sample calculation using a mean of 2.92 mm of the quantity of keratinized mucosa obtained after six months in the most recent study (McGUIRE; SCHEYER, 2014) using the same collagen matrix with a standard deviation of ± 0.88 mm, a difference of 0.4 mm being chosen as statistically significant. In addition, a 95% bilateral confidence interval and 80% power were used. A sample of 38 individuals per group was obtained. In addition, a 20% loss is expected during follow-up, a total of 46 individuals should be evaluated.

Periapical radiographic examinations should be performed before the collection of data to confirm the absence of bone loss. The following clinical parameters should be evaluated in both test and control groups: visible plaque index, gingival bleeding index, gingival recession, keratinized mucosa width and thickness, probing depth, bleeding on probing and periodontal biotype for each teeth with a North Carolina periodontal probe. The periodontal biotype for each teeth should be rated as thin or thick, according to probe transparency during probing depth. For statistical purposes, percentages of faces with gingival recession should be calculated. These parameters should be evaluated at baseline and at one, three and six months, one and two years post-therapy.

Clinical parameters should be collected by two operators, calibrated by the Kappa test for the keratinized mucosa width and thickness, periodontal biotype, probing depth and gingival recession.

After the inclusion of the patients, anamnesis and initial examination were performed. The subjects should be divided randomly, using a simple draw, in the following two groups: test - (collagen matrix) and control - (connective tissue graft) placebo associated with basic periodontal therapy). The data should be a
Sponsor: Universidade Federal do Rio Grande do Norte

Current Primary Outcome:

  • gingival recession [ Time Frame: baseline ]
  • gingival recession [ Time Frame: three months ]
  • gingival recession [ Time Frame: six months ]
  • gingival recession [ Time Frame: twelve months ]
  • gingival recession [ Time Frame: eighteen months ]
  • gingival recession [ Time Frame: twenty-four months ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Width of keratinized mucosa [ Time Frame: baseline and three, six, twelve, eighteen and twenty-four months ]

Original Secondary Outcome: Same as current

Information By: Universidade Federal do Rio Grande do Norte

Dates:
Date Received: November 28, 2016
Date Started: February 2017
Date Completion: February 2019
Last Updated: November 29, 2016
Last Verified: November 2016