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Effect of functional occlusal plate on orthognathic surgery stability in patients with jaw asymmetric deformity: study protocol for a multi-center, prospective randomized controlled trial

The influence of preoperative orthognathic occlusal splint treatment on the stability of temporomandibular joint in patients with temporomandibular disorders

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076898
Enrollment
Unknown
Registered
2023-10-24
Start date
2022-10-15
Completion date
Unknown
Last updated
2023-10-30

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

Conditions

Jaw asymmetric deformity

Interventions

Occlusal plate group:Functional occlusal plate will be worn before surgery
Non-occlusal plate group:No functional occlusal plates will be worn before surgery

Sponsors

Affiliated Stomatology Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ·Patients who have been diagnosed with jaw asymmetric deformity and need orthodontic orthognathic combined treatment. ·Age at study enrolment = 18 years and < 45 years of age. ·End of treatment for at least 12 months. ·Written informed consent (must be available before enrolment in the study).

Exclusion criteria

Exclusion criteria: ·Patients with a history of orthodontic treatment, systemic disease or maxillofacial trauma. ·Patients with insufficient follow-up time. ·Patients with incomplete follow-up data. ·Patients who were lost to follow-up or dropped out of the clinical trial.

Design outcomes

Primary

MeasureTime frame
Change of condyle position;

Secondary

MeasureTime frame
Change of mandibular sagittal position;Change of temporomandibular joint space;

Countries

China

Contacts

Public ContactXu Qiang

Affiliated Stomatology Hospital of Wenzhou Medical University

xuqiang9554@163.com+86 133 5339 2793

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026