Compare Fibro-Gide collagen membrane versus connective tissue graft to cover multiple areas of gum recession

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

This trial tests whether a synthetic collagen matrix (Fibro-Gide) can replace tissue taken from the roof of the mouth to cover multiple gum recession defects in adults.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The European Research Group on Periodontology (ERGOPerio) (network)
• Locations: 2 sites (Florence and 1 other locations)
• Trial ID: NCT07083050 on ClinicalTrials.gov

What this trial studies

This is a randomized, parallel-group, assessor-blind, multicenter trial comparing a volume-stable collagen matrix (VCMX, Geistlich Fibro-Gide®) to autologous connective tissue grafts harvested from the hard palate for treatment of multiple adjacent gingival recessions. The primary endpoint is non-inferiority of root coverage at 12 months, with secondary endpoints including complete root coverage, percent root coverage, professional aesthetic ratings, and patient-reported morbidity and recovery time. About 80 subjects per arm (roughly 200 recessions per arm) will be enrolled across centers using a multilevel statistical approach and a 0.25 mm non-inferiority margin. The design also tests superiority for patient-centered outcomes such as pain and recovery.

Who should consider this trial

Good fit: Adults age 18–70 with at least two adjacent maxillary anterior or premolar teeth with gingival recession (at least one ≥3 mm, RT1 or RT2 with ≤2 mm interdental attachment loss), ≥2 mm keratinized tissue, and no medical contraindications for elective oral surgery are ideal candidates.

Not a fit: Patients with greater interdental attachment loss (beyond RT2/RT3), active severe periodontal disease, or those requiring coverage across very extensive contiguous defects (involving more than five adjacent teeth across the arch) are unlikely to be helped by this protocol.

Why it matters

Potential benefit: If successful, the collagen matrix could provide similar root coverage while avoiding palate harvesting, reducing pain and shortening recovery.

How similar studies have performed: Previous randomized trials using similar collagen matrices (for example with Geistlich Mucograft®) have reported positive results, and this trial builds on that prior evidence to test Fibro-Gide.

Eligibility criteria

Inclusion Criteria:

* Male and female, 18 to 70 years of age, with a minimum of two adjacent teeth with gingival recession (at least one with a depth ≥ 3 mm - RT1 or RT2 with 2 mm or less of interdental periodontal attachment loss) in anterior and premolar teeth in the maxilla and requiring surgical intervention, without medical contraindications to elective surgery. In case of recessions on five or more adjacent teeth, the teeth at the external sides will not be included in the study.
* At least 2 mm marginal keratinized tissue width and irrespective of soft tissue thickness prior therapy. The study should involve treatment naïve patients in terms of root coverage procedures. Prior therapy should include treatment of gingival inflammation, if present, instructions in non-traumatic oral hygiene, and reconstruction of the cemento-enamel junction with adhesive dental materials in case of cervical abrasion or erosion involving this structure
* Evidence of subject ability to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS\<25% and FMBS\<25%)
* Ability to understand study procedures and to comply with them for the entire length of the study. Ability and willingness to give written informed consent.

Exclusion Criteria:

* Presence of untreated periodontitis
* Persistence of uncorrected gingival trauma from tooth brushing
* Interdental attachment loss greater than 2 mm or furcation involvement in the experimental teeth
* Presence of less than 2 mm of keratinized tissue width
* Presence of severe tooth malposition, rotation or clinically significant super-eruption
* Self reported current smoking exceeding 10 cigarettes/day or pipe or cigar smoking
* Rheumatoid arthritis or known sensitization to collagen based medical products.
* Presence of medical contraindications to elective surgery
* Participation in another interventional clinical trial
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Inability or unwillingness of individual to give written informed consent.
* Uncontrolled diabetes mellitus
* Allergy to collagen
* Pregnancy or lactation or sexually active female subjects who are of childbearing potential and who are not using hormonal or barrier methods of birth control (e.g., oral or parenteral contraceptives, diaphragm plus spermicide, condoms).
* Radiotherapy
* immunosuppressive therapy
* chronic steroid therapy (inhaler or systemic).

Where this trial is running

Florence and 1 other locations

• Ospedale Careggi — Florence, Italy (RECRUITING)
• International University of Catalunya — Barcelona, Spain (RECRUITING)

Study contacts

• Principal investigator: Maurizio Tonetti, DMD PhD — The European Research Group on Periodontology (ERGOPerio)
• Study coordinator: Maurizio Tonetti, DMD, PhD

Conditions: Gingival Recession, Plastic Surgery, Gingival recession, Root coverage, Collagen Construct, Connective tissue graft, Morbidity