RESUMEN
OBJECTIVES: To test the non-inferiority of demineralized bovine bone mineral (DBBM) compared to demineralized bovine bone mineral with 10% collagen (DBBM-C) for the maintenance of the soft tissue contour after tooth extraction in the esthetic zone. MATERIAL AND METHODS: Sixty-five patients randomly received ridge preservation at a single site in the anterior maxilla with DBBM or DBBM-C. Both, DBBM and DBBM-C, were covered with a collagen matrix. Profilometric analyses were performed at baseline (BL), immediately after treatment (PO), and at 4 months (FU; day of implant placement). The main outcome was the horizontal mean change (HC) at the buccal aspect. The measurements also included changes of the estimated soft tissue thickness (eTT) at 1, 3, and 5 mm below the buccal gingival margin. Descriptive analysis was performed, and differences between groups were analyzed using independent samples t test. The non-inferiority test was performed for HC. RESULTS: At 4 months, the horizontal mean change (HC) was -1.43 mm (±0.53 mm) (DBBM-C) and -1.32 mm (±0.53 mm) (DBBM). Change of the estimated soft tissue thickness (eTT) between baseline (BL) and four months of follow-up (FU) at 1, 3, and 5 mm amounted to -4.58 mm (±2.02 mm), -2.40 mm (±0.97 mm), and -1.37 mm (±0.78 mm) for DBBM-C and to -4.12 mm (±1.80 mm), -2.09 mm (±0.91 mm), and -1.23 mm (±0.72 mm) for DBBM. The differences between the groups were not statistically significantly for any of the outcome measures (p > .05). CONCLUSIONS: DBBM is non-inferior to DBBM-C for the maintenance of the soft tissue contour 4 months after tooth extraction.