Ossification of a novel cross-linked porcine collagen barrier in guided bone regeneration in dogs.

BACKGROUND Collagen membranes for guided bone regeneration (GBR) and guided tissue regeneration (GTR) are used extensively as bioabsorbable barriers. Cross-linking of collagen increases its biodurability and enables the control of its degradation kinetics and barrier function. A novel cross-linking technology was used to produce a porcine type I collagen membrane (GLYM). The purpose of this study was to evaluate the safety, efficacy, and degradation kinetics of GLYM compared to a non-cross-linked bilayer type I and III porcine collagen membrane (BCM) in surgically created defects in dogs. METHODS After tooth extraction, two mandibular bilateral critical size defects were created in 12 beagle dogs that were randomly assigned to one of five groups: GLYM + bovine bone mineral (BBM), BCM + BBM, BBM alone, sham-operated, or GLYM alone. Dogs were euthanized after 8, 16, and 24 weeks, and sites were prepared for qualitative, semiquantitative, and quantitative light microscopy analyses. RESULTS Membrane-protected sites displayed bone filling between the BBM particles with almost complete restoration of the original ridge morphology that increased with time up to 16 weeks and remained unchanged at 24 weeks. Both membranes showed marked degradation within 16 to 24 weeks, with BCM inconsistency that was undetectable in one of four sites at 8, 16, and 24 weeks. Membrane ossification was observed in all GLYM sites and in only one BCM site, which progressed with time to 24 weeks. Bone increased by approximately 1 mm on the lingual side, where the GLYM membrane was in direct contact with bone. CONCLUSIONS Both membranes were safe and effective in supporting bone regeneration in critical size alveolar ridge defects in dogs and completely degraded within 24 weeks with marked BCM inconsistency. In areas of direct contact with bone, all GLYM sites were progressively ossified with time and augmented the original alveolar ridge. To the best of our knowledge, this is the first report of complete ossification of a collagen barrier membrane in GBR procedures.