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Non-Inferiority of Fibroguide Collagen Membrane Compared to Autologous Connective Tissue Graft for Coverage of Multiple Adjacent Recession. Multicenter Trial.
Sponsor: Maurizio Tonetti
Summary
This study deals with coverage of multiple denuded roots. The current standard treatment requires surgical correction and uses soft tissue taken from the roof of the mouth to enhance results. The hypothesis of this trial is that a synthetic collagen matrix (called Fibrogide) can be used to replace soft tissue taken from the subject. If the collagen matrix will prove to be equally as effective as the patient own tissue, it will be possible to avoid a more extensive surgery and decrease pain and discomfort.
Official title: Connective Tissue Graft vs Volume Stable Collagen Matrix (Geistlich Fibro-Gide®) for Coverage of Multiple Gingival Recession Defects in Combination With Coronally Advanced Flap (CAF) Randomized Multicenter Controlled Clinical Trial Assessing Non-Inferiority in Root Coverage
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2015-07-12
Completion Date
2029-12-31
Last Updated
2025-08-07
Healthy Volunteers
No
Conditions
Interventions
Volume stable collagen matrix
Volume stable collagen matrix obtained from porcine collagen after proprietary cross-linking by device manufacturer
Autologous Connective Tissue Graft from the Hard Palate
Autologous connective tissue surgically harvested from the hard palate and transplanted in the area of gingival recession
Locations (2)
Ospedale Careggi
Florence, Italy
International University of Catalunya
Barcelona, Spain