A prospective multicenter randomized clinical trial of autogenous bone versus beta-tricalcium phosphate graft alone for bilateral sinus elevation: histologic and histomorphometric evaluation.

PURPOSE: Two different graft materials, beta-tricalcium phosphate (Cerasorb) and autogenous bone, were used in the same patient. The objective was to determine whether donor site morbidity could be avoided by using pure-phase beta-tricalcium phosphate (Cerasorb).
MATERIALS AND METHODS: Bilateral sinus grafting was performed on 20 selected patients; Cerasorb was used on the experimental side, and autogenous bone was used on the control side. In each patient, one side was randomly designated the experimental side. In 10 of the 20 patients, the maxilla reconstruction included sinus grafting and onlay bone grafting. Implants were placed 6 months after the procedure. In addition to routine panoramic radiographs, in 10 of the 20 patients, 2- and 3-dimensional computerized tomographic examinations were performed pre- and postoperatively and after implantation. Eighty bone biopsy specimens were taken at the time of implant placement.
RESULTS: Histologically and histomorphometrically, there was no significant difference between the experimental and control grafts in terms of the quantity and rate of ossification. For each histologic sample, the total surface area, the surface area that consisted of bone, and the surface area that consisted of graft material were measured in mm2, and bone and graft material were analyzed as percentages of the total. The mean percentage bone areas were 36.47% +/- 6.9% and 38.34% +/- 7.4%, respectively; the difference was not significant (P = .25). DISCUSSION AND
CONCLUSION: Comparisons with other studies reveal that beta-tricalcium phosphate (Cerasorb) is a satisfactory graft material, even without autogenous bone.

RCT Entities:   Population Interventions Outcomes