Filling intrabony periodontal defects with a volume-stable collagen matrix versus bovine bone mineral with 10% collagen
Treatment of Periodontal Intra-bony Defects With a Volume Stable Collagen Matrix or Deproteinized Bovine Bone Mineral With 10% Collagen. A 12-month Multi-center Randomized Controlled Trial
This trial will test whether a volume-stable collagen matrix or a deproteinized bovine bone graft with 10% collagen better helps adults with advanced periodontitis heal their intrabony defects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT06676826 on ClinicalTrials.gov |
What this trial studies
This interventional comparison treats intrabony periodontal defects by open flap debridement followed by filling the defect with either a volume-stable collagen matrix (VCMX) or deproteinized bovine bone mineral containing 10% collagen. Eligible participants are adults with Stage III–IV periodontitis who have single-aspect intrabony defects ≥3 mm and probing depths ≥6 mm. Surgical treatment is performed at the University of Bern and clinical healing and regenerative outcomes will be recorded and compared between the two graft materials. The study aims to clarify whether VCMX can serve as an alternative to bovine-derived grafts in regenerative periodontal surgery.
Who should consider this trial
Good fit: Adults (≥18 years) with Stage III–IV periodontitis who have a single-aspect intrabony defect ≥3 mm, probing depth ≥6 mm, at least 2 mm of keratinized tissue, and no systemic conditions that impair healing are ideal candidates.
Not a fit: Patients with systemic diseases that affect wound healing, heavy smokers (>10 cigarettes/day), poor oral hygiene after therapy, pregnant or lactating women, multi-rooted teeth with furcation involvement, circumferential defects, interdental craters, or third molars are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, a volume-stable collagen matrix could offer a synthetic graft option that improves bone fill and periodontal attachment while reducing reliance on animal-derived materials.
How similar studies have performed: Deproteinized bovine bone mineral with collagen has established positive clinical results in periodontal regeneration, while volume-stable collagen matrices are less extensively studied but have shown encouraging early outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Patients with localized or generalized periodontitis Stage III and Stage IV, Grade A-B-C * Males and females * Age at least 18 years and older * Presence of interdental intra-bony defects (I, II and III walls) in either the maxilla or the mandible with a PD ≥ 6 mm * Defects with an intra-bony component \> 3 mm for both groups * Intra-bony defect located only at one aspect (mesial or distal) * Presence of at least 2 mm of keratinized soft tissue. Exclusion Criteria * Patients with systemic disease that could interfere with periodontal wound healing * Prolonged antibiotic treatment or anti-inflammatory treatment within 4 weeks prior to surgery * Pregnant or lactating * Smokers with \> 10 cig./day * Patients with FMPS and FMBS \> 25 % after completion of non-surgical periodontal therapy * Multi-rooted teeth with furcation involvement * Third molars * Teeth with circumferential defects * Interdental craters * Written Informed Consent
Where this trial is running
Bern
- University of Bern — Bern, Switzerland (Recruiting)
Study contacts
- Study coordinator: Alexandra Stähli, MD
- Email: alexandra.staehli@unibe.ch
- Phone: +41316840600
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.