Randomized controlled trials of postoperative stability of HA-containing PLLA resorbable osteosynthesis material and metal osteosynthesis material in orthognathic surgery

JRCT ID: jRCT1032210351

Registered date:28/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Avoiding removal surgery
• Date of first enrollment: 28/09/2021
• Target sample size: 80
• Study type: Interventional
• Intervention(s): HA-containing resorbable osteosynthesis material is used for bone fragment fixation in bilateral mandibular branch sagittal division, which is one of the orthognathic surgeries.

Outcome(s)

• Primary Outcome: Bone fragment movement 1 month, 3 months, 6 months, and 12 months after the sagittal division of the mandibular branch

Secondary Outcome

Intraoperative bone fragment movement using the navigation system in the sagittal division of the mandibular branch
Number and length of screws used to fix the plate
age
sex
Angle classification for malocclusion

Key inclusion & exclusion criteria

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

Include criteria

1) Patients who are going to Showa University Dental Hospital Maxillofacial Surgery and are planning orthognathic surgery
2) Patients whose age at the time of obtaining consent is 18 to 60 years old.
3) Patients who have given written consent to participate in this study. If you are under the age of 20, be sure to obtain written consent from the consenter.

Exclude criteria

1) Patients with allergies to PLLA, HA or titanium
2) Patients with congenital oral diseases (patients with cleft lip and palate)
3) Patients with mandibular fragment movement exceeding 10 mm in preoperative simulation
4) Patients with facial asymmetry with a difference in bone fragment movement of 5 mm or more on the left and right in preoperative simulation
5) Other patients who are judged to be ineligible at the discretion of the research doctor

Related Information

• Primary Sponsor: Shirota Tatsuo