NCT03833765

Adjunctive Benefit of a Xenogenic Collagen Matrix

Adjunctive Benefit of a Xenogenic Collagen Matrix Associated With Coronally Advanced Flap for Treating Multiple Gingival Recessions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Roberto Rotundo · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The present CONSORT-based randomized clinical trial is to assess the adjunctive benefit of a xenogenic collagen matrix in combination with a coronal advanced flap with respect to a coronal advanced flap alone in the treatment of multiple gingival recession defects in adult population.

Detailed description

This is a single-centre, superiority, double blind clinical trial, with balanced randomisation and parallel two groups design. The 2 groups will be: 1. CAF combined with XCM; 2. CAF alone. The objective is therefore to assess the adjunctive benefit of a xenogenic collagen matrix in combination with a coronal advanced flap. The primary endpoint is the mean recession reduction after 6 and 12 months post treatment. The secondary endpoints are: Percentage of complete root coverage after 6 and 12 month; Thickness of soft tissue over the root after 6 and 12 month; Recession width after 6 and 12 month; KT width; Patients satisfaction. The following Inclusion Criteria have to be satisfied: patient (male or female) must be 18 years or older, not pregnant, and candidate for buccal root coverage procedure in the upper jaw; recession defects have to be AAA or ABA (according to Rotundo et al classification), with at least 2 adjacent RC with ≥ 2 mm RC depth and root abrasion depth less than 1 mm; Patient shows sufficient plaque control (FMPS ≤ 20%) and acceptable bleeding score(FMBS ≤ 20%); Teeth intended to treat are in the region 1 - 5; patient has to be able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures; patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent. Randomisation: Computer-generated blocked for each centre, with allocation concealment by opaque sequentially numbered sealed envelopes. Blinding: Patients and outcome assessor blind to group assignment. Sample size: Based on a formula for cluster design to detect a difference between treatments of 1 mm in recession reduction (standard deviation of 0.93 mm - Woodyard et al. 2004) with a two-side 5% significance level, a power of 90%, a mean number of treated teeth per patient of 2.92, an intraclass correlation coefficient of 0.35, a sample size of 24 patients per treatment will be necessary.

Conditions

• Gingival Recession

Interventions

Type	Name	Description
PROCEDURE	CAF+XCM	After flap elevation according to the Coronally Advanced Flap procedure for multiple recession defects, a Xenogeneic Collagen Matrix was applied and then covered by the flap.
PROCEDURE	CAF alone	Coronally Advanced Flap procedure alone was performed to treat multiple recession defects

Timeline

• Start date: 2012-11-28
• Primary completion: 2016-05-03
• Completion: 2017-07-17
• First posted: 2019-02-07
• Last updated: 2019-02-12