Randomized clinical trial for the biological evaluation of two nanostructured biphasic calcium phosphate biomaterials as a bone substitute.

BACKGROUND

The presence of nonresorbable residual granules of hydroxyapatite (HA) may decrease the bone/implant interface. To balance resorption and bone formation biphasic calcium phosphate ceramics compounds applied at different rates have been studied.

PURPOSE

The aim of this trial was to compare the clinical, histological, and histomorphometric responses of two new biphasic calcium phosphate biomaterials in fresh dental sockets after 3 and 6 months.

MATERIALS AND METHODS

Forty-eight volunteers were divided randomly and double-blindly into 4 groups of 12 individuals: Clot (C), BoneCeramic (BC), Biomaterial 1 (B1), and Biomaterial 2 (B2) groups. Three and six months later, samples were obtained, and histological and histomorphometric sections were evaluated, focusing on the presence of fibrous connective tissue (CT) and newly formed bone. Statistical analysis was performed (P < .05%).

RESULTS

The quantification of crystalline phases showed B1 composed of HA (60.28%) and β-TCP (39.72%); B2 composed of HA (78.21%) and β-TCP (21.79%); and BC composed of HA (61%) and β-TCP (39%). The B1 group showed the most newly formed bone (69.3% ± 6.03%), followed by the BC (51.6 ± 12.34%), B2 (46.6 ± 7.66%), and C groups (45.4 ± 7.98%), and less connective tissue and biomaterial remained in the B1 group after 6 months.

CONCLUSION

B1 group showed the greatest amount of newly formed bone after 6 months.

© 2017 Wiley Periodicals, Inc.