Actively Recruiting
Non-Inferiority of Fibroguide Collagen Membrane Compared to Autologous Connective Tissue Graft for Coverage of Multiple Adjacent Recession. Multicenter Trial.
Led by Maurizio Tonetti · Updated on 2025-08-07
160
Participants Needed
2
Research Sites
755 weeks
Total Duration
On this page
Sponsors
M
Maurizio Tonetti
Lead Sponsor
U
University of Florence
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Non-Inferiority of Fibroguide Collagen Membrane Compared to Autologous Connective Tissue Graft for Coverage of Multiple Adjacent Recession. Multicenter Trial.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female, 18 to 70 years old
- At least two adjacent teeth with gum recession, including one with 3 mm or deeper recession, in front or premolar teeth in the upper jaw
- At least 2 mm of keratinized gum tissue width
- Patients with no prior root coverage surgery but treated for gum inflammation and oral hygiene
- Good oral hygiene with plaque and bleeding scores under 25%
- Ability to understand and follow study procedures and provide written consent
You will not qualify if you...
- Untreated gum disease
- Unhealed gum injury from tooth brushing
- More than 2 mm attachment loss or furcation involvement in treated teeth
- Less than 2 mm keratinized gum tissue width
- Severe tooth misalignment, rotation, or significant over-eruption
- Current smoking exceeding 10 cigarettes/day or pipe or cigar use
- Rheumatoid arthritis or allergy to collagen products
- Medical conditions preventing elective surgery
- Participation in another interventional clinical trial
- Drug or alcohol use interfering with study adherence
- Inability or unwillingness to give informed consent
- Uncontrolled diabetes mellitus
- Pregnancy, breastfeeding, or sexually active females not using birth control
- Previous radiotherapy
- Immunosuppressive or chronic steroid therapy (inhaler or systemic)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Ospedale Careggi
Florence, Italy
Actively Recruiting
2
International University of Catalunya
Barcelona, Spain
Actively Recruiting
Research Team
M
Maurizio Tonetti, DMD, PhD
CONTACT
L
Luigi Barbato, DMD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here