Abstract
OBJECTIVES: Assessment of the clinical performance of a porcine dentin-derived particulate bone graft material for bone regeneration after tooth extraction with implant placement at 4 months, in comparison to a commercially available porcine bone-derived graft. MATERIAL AND METHODS: This study was a randomized, parallel-group, semi-double-blinded clinical trial evaluating the clinical safety, tolerability, and performance of Ivory Dentin Graft™ in comparison with a commercial bone-derived material in alveolar ridge preservation following tooth extraction (registered at ClinicalTrials.gov, May 12th, 2017, Identifier NCT03150472). Extraction sites were grafted with test or comparator material and a titanium implant placed at 4 months after taking a graft site biopsy. Primary endpoints were the extent of new bone growth and bone-graft integration at 4 months. RESULTS: The dentin graft material had statistically significantly more new bone formation (60.75% vs 42.81%, p = 0.0084, N = 20 vs 16), better bone-graft integration scores (good integration in 85% vs 40%, p = 0.0066), and higher mean radiodensity of the bone (981.5HU vs 727.7HU, p = 0.0011) at the graft site compared to the bone-derived material. The mean implant insertion torque force was similar for the dentin and bone materials (34.75 Ncm vs 34.06 Ncm). Titanium implant placement was successful in 95% of patients with the dentin graft material compared to 81.25% for the bone graft. Both materials had similar clinical safety and tolerability as determined by adverse events and local site reactions. Physician-assessed ease of grafting and ease of implant placement on a 10-point scale showed no statistical differences (8.78 vs 8.27, p = 0.2355; 8.05 vs 8.75, p = 0.1118, respectively). CONCLUSIONS: A porcine dentin-derived bone graft material has clinical safety, tolerability, and performance for implant placement at 4 months after tooth extraction at least as good as a commercial bone-derived material. CLINICAL RELEVANCE: The availability of porcine dentin-derived bone graft material allows wider use of dentin-derived material which has so far only been available in the form of autologous dentin from the patient's own teeth.