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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group (VCMX) | Experimental | The periodontal infrabony defect will be opened by a papilla preservation flap, the root surface will be thoroughly cleaned with hand instruments and ultrasonic scalers, then the bony defect will be filled with a volume-stable collagen matrix (VCMX) only. |
|
| Control Group (Deproteinized bovine bone mineral) | Active Comparator | The periodontal infrabony defect will be opened by a flap, the root surface will be thoroughly cleaned with hand instruments and ultrasonic scalers, then the bony defect will be filled with deproteinized bovine bone mineral with 10% collagen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infrabony defects will be filled with a volume-stable collagen matrix (VCMX) | Device | Infrabony defects will be filled with a volume-stable collagen matrix |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical attachment level (CAL) change | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological analysis | 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 | 1, 3, 12 weeks |
| Bleeding on probing (BoP) |
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Inclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Stähli, MD | Contact | +41316840600 | alexandra.staehli@unibe.ch | |
| Andrea Roccuzzo, PhD | Contact | +41316840600 | andrea.roccuzzo@unibe.ch |
| Name | Affiliation | Role |
|---|---|---|
| Alexandra Stähli, MD | University of Bern | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bern | Recruiting | Bern | 3010 | Switzerland |
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|
| Infrabony defects will be filled treated with a deproteinized bovine bone mineral with 10% collagen | Device | Infrabony defects will be filled with with a deproteinized bovine bone mineral with 10% collagen |
|
|
Assessment of number of bleeding spots (percentage 0-100%) upon gentle probing of PPD at each test and control tooth site |
| Baseline, 12 months |
| Pocket probing depth (PPD) | With a periodontal probe with mm markings, the distance between the gingival margin and the bottom of the pocket will be measured | Baseline, 12 months |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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