Using a collagen matrix to treat gum recession
Coronally Advanced Flap With Xenogenic Collagen Matrix or Autogenous Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recessions: a Randomized Controlled Trial
This study is testing whether a new collagen treatment can help people with gum recession feel better compared to a traditional gum graft method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Turin, Italy Academic / other |
| Locations | 1 site (Turin) |
| Trial ID | NCT05693753 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a xenogenic collagen matrix (XCM) compared to an autologous connective tissue graft (CTG) for treating multiple adjacent gingival recessions using a multiple coronally advanced flap technique (mCAF). The primary focus is on recession reduction, while secondary outcomes include changes in keratinized tissue width, probing pocket depth, and patient-reported outcomes such as pain and swelling. Participants will be monitored at 6 months and 1 year to assess the results of both treatment methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with multiple adjacent teeth exhibiting specific types of gingival recessions.
Not a fit: Patients with systemic diseases affecting therapy outcomes, current smokers, or those with a history of periodontal surgery on the involved teeth may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and more effective treatment option for patients with gum recession.
How similar studies have performed: Previous studies have shown promising results with similar approaches, but this specific comparison of XCM and CTG is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years old and able to sign informed consent * At least 2 adjacent teeth with RT1 and/or RT2 gingival recessions without interproximal exposure of the CEJ (interdental gingival recession), at least one with a depth of ≥2mm with indication for root coverage treatment * A minimum of 4 adjacent teeth (including the ones to be treated) in the region of interest * Available to attend study related procedures (including follow-up visits) Exclusion Criteria: * Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus); * Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers; * Pregnant or nursing women; * History of previous periodontal surgery (mucogingival or other) on the teeth to be included; * Furcation involvement in the teeth to be included; * Presence of severe tooth malposition, rotation or clinically significant extrusion in the teeth to be treated; * Presence of fixed or removable prosthesis in the area to be treated
Where this trial is running
Turin
- CIR Dental School — Turin, Italy (Recruiting)
Study contacts
- Study coordinator: Mario Aimetti, MD
- Email: mario.aimetti@unito.it
- Phone: 0116331546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.