title: Clinical safety and efficacy of implantation of octacalcium phosphate collagen composites in tooth extraction sockets and cyst holes.
abstract: It was demonstrated that octacalcium phosphate collagen composite achieved notable bone regeneration in bone defects in preclinical studies. On the basis of the research results, an investigator-initiated exploratory clinical trial was conducted after approval from a local Institutional Review Board. This clinical study was performed as a single-arm non-randomized intervention study. Octacalcium phosphate collagen composite was implanted into a total of 10 cases of alveolar bone defects after tooth extractions and cystectomy. Safety assessment was performed in terms of the clinical course and several consecutive laboratory examinations, and sequential radiographs were used for efficacy assessment. All participants uneventfully completed the clinical trial without major problems in their general condition. Postoperative wound swelling was observed, as also commonly seen in tooth extraction or cystectomy. Although no serious liver dysfunction, renal dysfunction, electrolyte imbalance, or abnormal urinalysis results were recognized, the number of white blood cells and C-reactive protein level temporarily increased after the operation. An increase in radiopacity in the octacalcium phosphate collagen composite-implanted site was observed in all cases. Finally, the border between the original bone and the octacalcium phosphate collagen composite-implanted site became indistinguishable. These results suggest that octacalcium phosphate collagen composite could be utilized safely in clinical situations in the future.
authors.affiliation: Division of Oral and Maxillofacial Surgery, Tohoku University Graduate School of Dentistry, Sendai, Japan.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Kawai
authors.affiliation: Division of Oral and Maxillofacial Surgery, Tohoku University Graduate School of Dentistry, Sendai, Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Tanuma
authors.affiliation: Division of Oral and Maxillofacial Surgery, Tohoku University Graduate School of Dentistry, Sendai, Japan.
authors.forename: Keiko
authors.initials: K
authors.lastname: Matsui
authors.affiliation: Division of Craniofacial Function Engineering, Tohoku University Graduate School of Dentistry, Sendai, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Suzuki
authors.affiliation: Division of Oral and Maxillofacial Surgery, Tohoku University Graduate School of Dentistry, Sendai, Japan.
authors.forename: Tetsu
authors.initials: T
authors.lastname: Takahashi
authors.affiliation: Bone Regenerative Engineering Laboratory, Graduate School of Biomedical Engineering, Tohoku University, Sendai, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Kamakura
keywords: Bone regeneration; bone tissue engineering; calcium phosphate; collagen