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Safety and Effectiveness of Rebosis in orthognathic surgery

Research of the safety and effectiveness of the artificial bone substitute Rebosis in orthognathic surgery (LeFort I Osteotomy)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062250071
Enrollment
30
Registered
2025-12-08
Start date
2026-01-13
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaw deformity Bone defect

Interventions

Rebosis is inserted into the bone gap created by Lefort I osteotomy.

Sponsors

Iwata Eiji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with jaw deformity who will undergo LeFort I osteotomy between the time of jRCT publication and September 30, 2027, and who are 18 years of age or older at the time of obtaining informed consent. 2) Patients who have received a sufficient explanation of this study, fully understood the study, and voluntarily provided written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients who have extremely poor oral hygiene 2) Patients with unmanageable severe systemic disease, bleeding disease, endocrine disease 3) Drug, alcohol, nicotine addiction patients 4) Patients with diseases that require regular steroid or immunosuppressants administration 5) Patients receiving bone-modifying drugs 6) In addition, patients who are judged by the principal investigator and the investigator to be inappropriate as research subjects

Design outcomes

Primary

MeasureTime frame
Incidence of wound infection and wound dehiscence

Secondary

MeasureTime frame
Bone union, degree of bone hardening, and reduction of defect area at 6 and 12 months after surgery

Contacts

Public ContactEiji Iwata

Okayama University Hospital

eiwata@okayama-u.ac.jp+81-86-235-6702

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026