Usefulness of intraoperative image support system in orthognatic surgery

JRCT ID: jRCT1032220599

Registered date:01/02/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Jaw deformity
• Date of first enrollment: 01/02/2023
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Using an intraoperative image support system when performing orthognathic surgery

Outcome(s)

Primary Outcome

Intraoperative confirmation and evaluation of bone fragment movement by preoperative simulation
In jawbone plastic surgery, separated bone fragments are created and refixed, and the amount of movement of the bone fragments is quantified based on an arbitrary anatomical landmark as an evaluation item.

Secondary Outcome

Operation time
Bleeding volume
Presence or absence of mental nerve palsy and TMJ symptoms
Postoperative infection frequency and number of days of antibiotic administration
Hospitalization days

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 60age old
• Gender: Both

Include criteria

1) Clinical diagnostic criteria for jaw deformity in patients admitted to or outpatients at the Department of Maxillofacial and Maxillofacial Surgery, Showa University Dental Hospital
Patients who meet
2)Patients scheduled to undergo surgery for jaw deformity using an intraoperative image support system at our hospital.
3) Patients aged between 18 and 60 at the time of informed consent.
4) Patients who have completed preoperative orthodontic treatment by the time consent is obtained.
5)Patients who gave their written informed consent to participate in this study. If the applicant is under 20 years of age, written consent must be obtained from the legal representative.

Exclude criteria

1) When there is a request for discontinuation from the subject (or legally acceptable person)
2) If the study is interrupted due to the subject's circumstances (move, change doctor/hospital, busy schedule, loss of follow-up, etc.)
3) When it turns out that the subject is not a target case after the start of the study
4) In the event of an accidental accident
5) When an adverse event occurs (including aggravation of the primary disease, aggravation of complications or complications) and the investigator judges that the study should be discontinued
6) When it becomes difficult to continue the study due to insufficient effect or worsening of symptoms
7) If there is a serious deviation from this study protocol and it is judged that it cannot be evaluated
8) When it turns out that the subject did not take the medicine as instructed by the investigator
9) In addition, if the investigator judges that it is difficult to continue the study and it is appropriate to discontinue the study.

Related Information

• Primary Sponsor: Shirota Tatsuo