First Clinical Application of New Bone Substitute Material to the Alveolar Cleft


Secondary bone grafting of alveolar cleft using autologous particulate cancellous bone from the ilium is an essential treatment for cleft lip/palate patients. However, secondary surgical invasion represents a disadvantage. To avoid this disadvantage, octacalcium phosphate collagen composites (OCP/Col) were developed as a new bone substitute material. Through preclinical studies and clinical application for cyst holes and extraction sockets, OCP/Col demonstrated satisfactory bone repair. In this case report, OCP/Col alone was implanted into a 13-year-old patient with incomplete unilateral cleft lip and alveolus. Postoperative changes of the OCP/Col treated site were evaluated by computed tomography for two years after operation. It was revealed that sufficient bone bridge was formed in the treated alveolar cleft after implantation of OCP/Col without autologous bone grafting. At the bottom of the nasal cavity, preoperative asymmetry was improved. In addition, usual orthodontic treatment was completed 1 year and 10 months postoperatively, and good occlusion was achieved. These results suggest that OCP/Col is clinically applicable as bone regenerative material, representing an alternative to autologous bone grafting.

Autologous bone grDіing into the alveolar cleі has become indispensable for occlusion management in cleі lip/palate patients with alveolar cleі since the report by Boyne and Sands, and is a part of the routine treatment. Until now, transplantation of autologous iliac bone has been conducted selectively for jaw bone defects in the field of oral surgery. However, secondary surgical invasion to a healthy part of the body is inevitable when accessing a bone donor site, and physical limitations exist to the amount of bone that can be harvested. In addition, although the risk of complications such as paresthesia and hernia exists, the incidence of such complications is low. To eliminate such disadvantages, various bone substitute materials have been studied in recent years, but a satisfactory alternative to autologous bone has yet to be developed. Nard et al. searched the literature for articles on non-autologous materials used for alveolar cleіs, and they found reports dating back to the mid-1970s, but reports have hit new peaks in recent years. For the preceding four decades, autologous bone grDіing has been the gold standard. Groups from Tohoku University first investigated diskshaped octacalcium phosphate/collagen composites (OCP/Col) as a bone substitute synthesized using both synthetic OCP (Ca8H2 (PO4 )6 ·5H2O) and atelocollagen derived from porcine skin. OCP/Col has been applied to various DrtificiDl bone defect models in beagle dogs and excellent bone regenerative ability has been reported. Also, the first clinical application in humans confirmed the safety of this material [14], and bone regenerative ability in tooth extraction sockets and cystshas since been described. Нen, it was conducted a multicentre single-group trial (UMIN: 000018192) in a company-initiated clinical trial using OCP/Col for bone defects in the field of oral surgery. As part of this clinical trial, OCP/Col was implanted into the alveolar cleі of patients with unilateral cleі lip and alveolus. Нis study is the first clinical evaluation of OCP/Col being implanted into the alveolar cleі.

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Journal of Clinical Trials