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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: maurizio.tonetti@ergoperio.eu
• Phone: 393473289709

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TCAF versus MTUN with soft tissue grafts for a single gum recession in the lower premolar area

  This compares whether a tunneled coronally advanced flap (TCAF) or a modified tunnel (MTUN), each combined with a connective tissue graft, gives better root coverage for adults with a single gum recession in the lower premolar area.

  Recruiting University Hospital, Ghent · Ghent, Oost-Vlaanderen · NCT07158541

• CAF versus TCAF with connective tissue grafts for multiple maxillary gum recessions

  This comparison will test whether coronally advanced flap (CAF) or tunneled coronally advanced flap (TCAF), each combined with a connective tissue graft, provides better root coverage for adults with multiple gum recessions in the upper jaw.

  Recruiting University Hospital, Ghent · Ghent, Oost-Vlaanderen · NCT07158528

• Comparing two gum‑repositioning surgeries with connective tissue grafts for multiple recessions in the lower front teeth

  This trial will test whether the coronally advanced flap (CAF) or the tunneled coronally advanced flap (TCAF), both with connective tissue grafts, gives better root coverage for people with multiple gum recessions on their lower front teeth.

  Recruiting University Hospital, Ghent · Ghent, Oost-Vlaanderen · NCT06940050

• Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft

  This trial tests if applying low-level laser therapy or hyaluronic acid after free gingival graft helps healing in adults with insufficient keratinized tissue in the lower front teeth.

  Recruiting Altinbas University · Istanbul, Bakırköy · NCT07751211

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.