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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032210351
Enrollment
80
Registered
2021-09-28
Start date
2021-09-28
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Avoiding removal surgery Jaw deformity

Interventions

HA-containing resorbable osteosynthesis material is used for bone fragment fixation in bilateral mandibular branch sagittal division, which is one of the orthognathic surgeries.
HA-containing resorbable osteosynthesis material

Sponsors

Shirota Tatsuo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Bone fragment movement 1 month, 3 months, 6 months, and 12 months after the sagittal division of the mandibular branch

Secondary

MeasureTime frame
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

Contacts

Public ContactTakanobu Inada

Maxillofacial Oral Surgery

inada-t-5@dent.showa-u.ac.jp+81-3-3787-1151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026