Periodontal Diseases
Conditions
Brief summary
To compare the healing of intrabony periodontal defects treated with either open flap debridement and a volume-stable collagen matrix (VCMX) or a deproteinized bovine bone mineral with 10% collagen. The results will shed light on the clinical potential of VCMX in regenerative periodontal surgery and help to develop new treatment strategies.
Interventions
DEVICEInfrabony defects will be filled with a volume-stable collagen matrix (VCMX)
Infrabony defects will be filled with a volume-stable collagen matrix
DEVICEInfrabony defects will be filled treated with a deproteinized bovine bone mineral with 10% collagen
Infrabony defects will be filled with with a deproteinized bovine bone mineral with 10% collagen
Sponsors
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level (CAL) change | 12 months | Clinical attachment level (CAL) change in mm: the distance from the cemento-enamel junction to the bottom of the clinical periodontal pocket is being measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on probing (BoP) | Baseline, 12 months | Assessment of number of bleeding spots (percentage 0-100%) upon gentle probing of PPD at each test and control tooth site |
| Pocket probing depth (PPD) | Baseline, 12 months | With a periodontal probe with mm markings, the distance between the gingival margin and the bottom of the pocket will be measured |
| Microbiological analysis | 1, 3, 12 weeks | Quantification of the concentration of host-derived biomarkers (interleukin-1beta (IL-1b), IL-10, matrix-metalloproteinase- 8(MMP-8)) and periodontal bacterial species by means of gingival crevicular fluid and the biofilm sampling |
Countries
Switzerland
Contacts
Primary ContactAlexandra Stähli, MD
Backup ContactAndrea Roccuzzo, PhD
Outcome results
None listed