Journal of Periodontal and Implant Science

Korean Academy of Periodontology (대한치주과학회)
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Evaluation of the clinical and radiographic effectiveness of treating peri-implant bone defects with a new biphasic calcium phosphate bone graft: a prospective, multicenter randomized controlled trial

  • Jae-Hong Lee (Department of Periodontology, College of Dentistry and Institute of Oral Bioscience, Jeonbuk National University) ;
  • Hyun-wook An (Research & Development Center, MegaGen Implant Co., Ltd.) ;
  • Jae-Seung Im (Research & Development Center, MegaGen Implant Co., Ltd.) ;
  • Woo-Joo Kim (Department of Periodontology, College of Dentistry and Institute of Oral Bioscience, Jeonbuk National University) ;
  • Dong-Won Lee (Department of Periodontology, Gangnam Severance Hospital, College of Dentistry, Yonsei University) ;
  • Jeong-Ho Yun (Department of Periodontology, College of Dentistry and Institute of Oral Bioscience, Jeonbuk National University)
  • Received : 2023.01.27
  • Accepted : 2023.05.03
  • Published : 2023.08.31
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Abstract

Purpose: Biphasic calcium phosphate (BCP), a widely used biomaterial for bone regeneration, contains synthetic hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP), the ratio of which can be adjusted to modulate the rate of degradation. The aim of this study was to evaluate the clinical and radiographic benefits of reconstructing peri-implant bone defects with a newly developed BCP consisting of 60% β-TCP and 40% HA compared to demineralized bovine bone mineral (DBBM). Methods: This prospective, multicenter, parallel, single-blind randomized controlled trial was conducted at the periodontology departments of 3 different dental hospitals. Changes in clinical (defect width and height) and radiographic (augmented horizontal bone thickness) parameters were measured between implant surgery with guided bone regeneration (GBR) and re-entry surgery. Postoperative discomfort (severity and duration of pain and swelling) and early soft-tissue wound healing (dehiscence and inflammation) were also assessed. Data were compared between the BCP (test) and DBBM (control) groups using the independent t-test and the χ2 test. Results: Of the 53 cases included, 27 were in the test group and 26 were in the control group. After a healing period of 18 weeks, the full and mean resolution of buccal dehiscence defects were 59.3% (n=16) and 71.3% in the test group and 42.3% (n=11) and 57.9% in the control group, respectively. There were no significant differences between the groups in terms of the change in mean horizontal bone augmentation (test group: -0.50±0.66 mm vs. control groups: -0.66±0.83 mm, P=0.133), postoperative discomfort, or early wound healing. No adverse or fatal complications occurred in either group. Conclusions: The GBR procedure with the newly developed BCP showed favorable clinical, radiographic, postoperative discomfort-related, and early wound healing outcomes for peri-implant dehiscence defects that were similar to those for DBBM.

Keywords

Acknowledgement

This work was supported by a Korea Medical Device Development Fund grant funded by the Korean government (project number: KMDF_PR_20200901_0299).

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