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JAPANESE
JRCT ID: jRCTs062250071

Registered date:08/12/2025

Safety and Effectiveness of Rebosis in orthognathic surgery

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedJaw deformity
Date of first enrollment13/01/2026
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)Rebosis is inserted into the bone gap created by Lefort I osteotomy.

Outcome(s)

Primary OutcomeIncidence of wound infection and wound dehiscence
Secondary OutcomeBone union, degree of bone hardening, and reduction of defect area at 6 and 12 months after surgery

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1) Patients with jaw deformity who will undergo LeFort I osteotomy within nine months of approval by jRCT 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.
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Eiji Iwata
Address 2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama Okayama Japan 700-8558
Telephone +81-86-235-6702
E-mail eiwata@okayama-u.ac.jp
Affiliation Okayama University Hospital
Scientific contact
Name Eiji Iwata
Address 2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama Okayama Japan 700-8558
Telephone +81-86-235-6702
E-mail eiwata@okayama-u.ac.jp
Affiliation Okayama University Hospital