The effects of β-TCP and/or xenogeneic bone substitute on alveolar ridge preservation: a randomized clinical trial.

Objective: After tooth extraction, the alveolar ridge undergoes significant absorption, and the alveolar ridge preservation (ARP) will alleviate the complexity of implantation operations in specific clinical occasions and then improve the functionality and aesthetics of subsequent restoration. However, the effectiveness of β-tricalcium phosphate (β-TCP) composite materials for ARP needs to be confirmed by more clinical trials and more sufficient evidence. This study was aimed at evaluating the effects of β-TCP coating porous bovine deproteinization bone (β-TCP/PBDB) on ARP when compared with Bio-Oss®.

Methods: After baseline clinical examination, teeth extractions and the ARP were conducted randomly by β-TCP/PBDB or the Bio-Oss®. A collagen sponge was applied over the bone substitutes. After 6 months, clinical examination and cone-beam computerized tomography (CBCT) imaging analysis were conducted to evaluate the changes in alveolar bone volume.

Results: In the clinical trial, a total of 123 patients successfully completed the protocol. The surgical socket and the soft tissues healed well. The reduction of alveolar ridge width was 1.27 ± 1.32 mm, 0.89 ± 1.31 mm, and 0.63 ± 1.37 mm at three levels (1 mm, 3 mm, 5 mm) below the crest of alveolar ridge respectively using β-TCP/PBDB, while those were 1.12 ± 1.65 mm, 0.55 ± 1.41 mm, 0.56 ± 1.32 mm respectively in the Bio-Oss® group. The reduction of alveolar ridge height was 0.75 ± 1.96 mm in buccal and 0.95 ± 1.96 mm in lingual using β-TCP/PBDB while those were 1.01 ± 2.44 mm and 0.99 ± 2.13 mm respectively in the Bio-Oss® group. There is no significant difference in the width and height changes of the alveolar ridge compared to Bio-Oss® (p > 0.05).

Conclusions: This prospective, randomized, controlled clinical trial provided evidence that β-TCP/PBDB is a safe material and the effectiveness of β-TCP/PBDB in maintaining the volume and contour of the alveolar ridge is comparable to that of the Bio-Oss® material. Conclusions: The β-TCP/PBDB can be used as one option of bone substitute material for ARP.