Actively Recruiting
Connective Tissue Graft versus Volume Stable Collagen Matrix (Geistlich Fibro-Gide ae) for Multiple Gingival Recession Coverage Using Coronally Advanced Flap: Randomized Multicenter Controlled Trial Assessing Root Coverage Non-Inferiority
Led by Maurizio Tonetti · Updated on 2025-08-07
160
Participants Needed
2
Research Sites
156 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 research aims to evaluate a new treatment for covering multiple adjacent gingival recession defects. The study compares the standard surgical method using soft tissue taken from the roof of the mouth with a synthetic collagen matrix called Fibro-Gide. The goal is to see if the collagen matrix can provide similar root coverage while potentially reducing the extent of surgery, pain, and discomfort. This trial is a randomized, multicenter, controlled study conducted in academic and practice-based centers across Italy, Germany, and Spain. Participants will receive root coverage surgery using coronally advanced flaps combined either with the volume stable collagen matrix (Fibro-Gide) or with an autologous connective tissue graft harvested from the patient's palate. Treatments will be standardized and delivered by experienced clinicians. The study includes two groups: one receiving the collagen matrix and the other receiving the standard connective tissue graft. Follow-up will last up to 1 year with an additional long-term observation of 3 years for extended data collection. During the study, participants will undergo clinical evaluations of root coverage and aesthetics by blinded examiners at each center. Patient questionnaires and diaries will be used to assess recovery time and quality of life related to oral health at multiple time points up to 36 months. Safety and adverse events, including complete root coverage and professional aesthetic assessments, will be monitored. The primary outcome is root coverage after 12 months, with secondary outcomes including complete root coverage, time to recovery, and oral health quality of life measures.
CONDITIONS
Brief 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 participants aged 18 to 70 years
- Have at least two adjacent teeth with gingival recession, including one with a depth of 3 mm or more (RT1 or RT2 with 2 mm or less interdental attachment loss)
- Teeth involved are in the anterior and premolar areas of the upper jaw (maxilla)
- At least 2 mm of keratinized gum tissue width
- No prior root coverage surgery; prior treatment of gum inflammation and oral hygiene instructions completed
- Ability to maintain good oral hygiene with plaque and bleeding scores below 25%
- Able to understand and comply with study procedures and provide written informed consent
You will not qualify if you...
- Untreated periodontitis
- Ongoing gum injury from tooth brushing
- Interdental attachment loss greater than 2 mm or furcation involvement on affected teeth
- Less than 2 mm of keratinized gum tissue width
- Severe tooth misalignment, rotation, or significant over-eruption
- Current smoking of more than 10 cigarettes per day or pipe/cigar use
- Rheumatoid arthritis or allergy to collagen-based medical products
- Medical conditions that prevent elective surgery
- Participation in another interventional clinical trial
- Drug or alcohol dependence interfering with study adherence
- Unable or unwilling to provide written informed consent
- Uncontrolled diabetes mellitus
- Pregnancy, breastfeeding, or women of childbearing potential not using reliable birth control
- Prior radiotherapy
- Immunosuppressive or chronic steroid therapy (inhaled or systemic)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Surgery day plus the first two post-operative weeks
Participants undergo root coverage surgery using coronally advanced flaps with either volume stable collagen matrix or autologous connective tissue graft from the hard palate. Immediate post-operative care follows surgery.
Approximately 6 post-operative visits during the first two weeks
Duration - Up to 12 months with extended monitoring up to 3 years for long-term data collection
Participants are monitored to assess root coverage outcomes, aesthetics, time to recovery, and oral health related quality of life after surgery.
Visits at 3, 6, 12, 24, and 36 months
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
L
Luigi Barbato, DMD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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