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) studied | Jaw deformity |
| Date of first enrollment | 13/01/2026 |
| Target sample size | 30 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Rebosis is inserted into the bone gap created by Lefort I osteotomy. |
Outcome(s)
| Primary Outcome | Incidence of wound infection and wound dehiscence |
|---|---|
| Secondary Outcome | Bone 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 maximum | Not applicable |
| Gender | Both |
| Include criteria | 1) 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 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 |
Related Information
| Primary Sponsor | Iwata Eiji |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
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 |
| 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 |
| eiwata@okayama-u.ac.jp | |
| Affiliation | Okayama University Hospital |