Preclinical Evaluation of a Crown-Splinted Custom Root-Shaped Implant

Objective: To test whether a Maryland bridge-type splint provides adequate stability for a custom root-shaped implant to osseointegrate in a manner substantially equivalent to that of a threaded implant. Methods: Six beagle dogs were subjected to intraoral impressions and cone beam scans that were used to fabricate custom root-shaped implants (RTIs) and crowns. Premolars in the mandible (P4) and in the maxilla (P3) were extracted, and 24 RTIs were immediately placed in extraction sockets. Splint extensions of the crowns were bonded to mesial and distal teeth. Twelve mandibular molars (M2) were extracted, and threaded implants (DXI), serving as controls, were placed immediately. Animals were placed on a soft diet after surgery. Weekly intraoral photographs and radiographs were taken, and animals were sacrificed at 4 months. Fluorescent labels were injected 35, 21, and 7 days before sacrifice. Clinical implant stability and vertical pullout forces were tested, and loss of vertical bone height was measured on radiographs. Histomorphometric measurements of percent bone-to-implant contact (BIC) and mineral apposition rates were made from undecalcified sections. Results: Three RTI splints broke or debonded, and the implants were removed. No loss of DXI implants was noted. All remaining implants were clinically stable. Mean pullout forces were 366.7 ± 182.8 N for RTI (no pullout data for the threaded DXI). Mean vertical bone loss was 0.4 ± 0.6 mm mesially and 0.2 ± 0.7 mm distally for RTI and 0.8 ± 1.1 mm mesially and 0.8 ± 1.0 mm distally for DXI, with no significant differences between groups. BIC values were 70.8% ± 12.7% for mandibular RTI, 68.3% ± 11.6% for maxillary RTI, and 78.8% ± 5.5% for DXI. Mineral apposition rates within local osteons were 1.9 ± 0.5 μm for RTI and 1.7 ± 0.3 μm for DXI; at the implant surface, they were 2.5 ± 1.2 μm for RTI and 3.3 ± 1.8 μm for DXI, with no significant differences between groups. Conclusion: All RTIs with intact splints exhibited clinically successful integration, similar to that of control threaded implants. The RTI may be a viable option for single-tooth replacement. Keywords: bone-to-implant contact, custom implant, custom root-shaped implant, immediate loading, mineral apposition rate, REPLICATE Immediate Tooth Replacement System