Volume-stable collagen matrix to cover gum recession on teeth
Assessment of Connective Tissue Graft vs. a New Collagen Matrix for Periodontal Tissue Thickening and Coverage of Single or Multiple Adjacent Gingival Recessions of Orthodontically Treated Patients. A Randomized Clinical Trial
This test checks whether a new volume-stable collagen matrix can replace a connective tissue graft from the palate to cover buccal gum recessions in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT07437417 on ClinicalTrials.gov |
What this trial studies
This interventional comparison treats patients with standard periodontal surgical techniques (coronally advanced flap or tunnel) using either an autologous connective tissue graft from the palate or a novel volume-stable collagen matrix. Treatments follow the Department of Periodontology protocols and target buccal Miller Class I–III gingival recessions greater than 3 mm on canines and incisors. Outcomes include the amount of root coverage, tissue thickness/volume stability, healing, and patient-reported morbidity such as pain and recovery. Participants are followed through postoperative visits to compare clinical results and adverse events between the two approaches.
Who should consider this trial
Good fit: Adults with buccal Miller Class I–III gingival recessions greater than 3 mm on maxillary or mandibular canines or incisors who are otherwise healthy and able to give informed consent.
Not a fit: Patients with bleeding disorders, uncontrolled diabetes, recent head/neck radiation, infections, cardiac conditions requiring antibiotic prophylaxis, those taking medications that affect the gingiva, or who are pregnant or breastfeeding were excluded and are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, patients could achieve similar root coverage with less pain and no need for a second (palatal) surgical site, shortening recovery and lowering donor-site morbidity.
How similar studies have performed: Prior studies of collagen matrices and xenogeneic grafts have shown promising root coverage and reduced donor-site morbidity compared with palatal grafts, although autologous connective tissue grafts often remain the clinical gold standard.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent * Healthy patients referred to the clinic for recession coverage * Miller Class I, II or III facial gingival recession (GR) defect, \>3 mm, located on the buccal of the maxillary or mandibular canine and incisor area. Exclusion Criteria: * History of diseases with hypocoagulability, instable diabetes mellitus, post-irradiation in the head and neck area, infectious diseases or heart diseases that need prophylactic antibiosis before dental treatments or a medication with effect on the gingiva: Ciclosporin A, compounds of Phenytoin, calcium channel blockers, pregnant or breastfeeding patients
Where this trial is running
Bern
- Department of Periodontology — Bern, Switzerland (Recruiting)
Study contacts
- Study coordinator: Anton Sculean, Prof
- Email: anton.sculean@unibe.ch
- Phone: +41 31 684 06 20
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.