Comparison between two bone substitutes for alveolar ridge preservation after tooth extraction: Cone-beam computed tomography results of a non-inferiority randomized controlled trial.

Aim: To test the non-inferiority of demineralized bovine bone mineral (DBBM) compared to DBBM with 10% collagen (DBBM-C) for maintenance of bone volume after tooth extraction in the anterior maxilla.

Materials And Methods: Sixty-six patients were randomly treated with DBBM or DBBM-C, both of which were covered with a collagen matrix for ridge preservation in the anterior maxilla. Cone-beam computed tomographic analysis was performed immediately and 4 months after treatment. The primary outcome, for which non-inferiority of DBBM was tested, was change in the horizontal ridge width 1 mm below the buccal alveolar crest (HW-1) 4 months after extraction.

Results: Four months after extraction, HW-1 measured -1.60 mm ± 0.82 mm for DBBM-C, while the DBBM group showed a mean loss of -1.37 mm ± 0.84 mm (p = 0.28, 0.23 [95% CI: -0.19; 0.64]). The horizontal ridge width at 3 mm (HW-3) showed -0.98 mm (±0.67 mm) for DBBM-C and -0.84 mm (±0.62 mm) for DBBM (p = 0.40, 0.12 [95% CI: -0.19; 0.45]), and the horizontal ridge width at 5 mm (HW-5) showed -0.67 mm (±0.47 mm) for DBBM-C and -0.56 mm (±0.48 mm) for DBBM (p = 0.36, 0.11 [95% CI: -0.13; 0.34]).

Conclusions: The present clinical trial demonstrated non-inferiority of DBBM compared to DBBM-C for maintenance of alveolar bone volume 4 months after tooth extraction in the anterior maxilla.