Bi-Layered Biphasic Calcium Phosphate Bone Substitute to Improve Bone Formation in Lateral Jaw Defects Applying the Principle of Guided Bone Regeneration (GBR)-A Pre-Clinical Randomized Controlled Study.

Aim: To evaluate the application of a synthetic bi-layered biphasic calcium-phosphate (BBCP) bone substitute for its capacity for new bone formation in Guided Bone Regeneration (GBR) in an acute-defect model in Beagle dogs.

Material and methods: Standardized bone defects were created following the extraction of the maxillary ¹P¹, ²P², ⁴P⁴ and the mesial root of ³P³ in six Beagle dogs. The defects were treated according to the GBR principle using the tested material, synthetic bi-layered biphasic calcium-phosphate bone substitute (Group T), deproteinized bovine bone mineral (DBBM, positive control = PC), a mixture of the test substance and DBBM in a ratio of 1:1 (Group M) and a sham-operated empty control (negative control = NC). The defects were covered with a resorbable collagen barrier membrane. Bone formation was evaluated radiologically, microtomographically, and histomorphometrically after 11 weeks of healing.

Results: All biomaterials resulted in increased volume of the augmented bone compared to the negative control. The augmented ridge volume developed to a greater extent in the tested area and in the combination of the tested bone substitute and the DBBM compared to the positive control alone (DBBM). A significant increment in a mineralized tissue and bone-biomaterial contact was observed between the test groups and the positive control.

Conclusions: The synthetic BBCP appeared to result in greater bone formation volumes than the positive control (DBBM) and resulted in less contact with soft tissue. Hence, the tested material appeared to be at least as effective as the applied standard for lateral bone augmentation (DBBM).