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Clinical Study on Functional Orthopedic Appliance for Treating Dentofacial Deformities Caused by Joint-Derived Disorders

Clinical Study on Functional Orthopedic Appliance for Treating Dentofacial Deformities Caused by Joint-Derived Disorders

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095688
Enrollment
Unknown
Registered
2025-01-10
Start date
2024-11-13
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Dentofacial Deformities Caused by Joint-Derived Disorders

Interventions

Surgical treatment group:Disc repositioning by surgery.
Articular disc repositioning by surgery combined with pre-operative orthodontic functional appliance.:Use orthodontic functional appliance before surgery.

Sponsors

The Affiliated Stomatological Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1) Patients aged 12 to less than 20 years, diagnosed by MRI with TMJ anterior disc displacement without reduction, accompanied by mandibular deviation (condylar point distance from the midline greater than 2mm) and Class II malocclusion (SNB > 76.2 and ANB > 4.7). 2) MRI and CBCT will be conducted preoperatively, postoperatively, and during follow-up. 3) Patients will be informed and willing to participate in the clinical study and sign the informed consent form. 4) Undergoing surgical treatment for the temporomandibular joint disc.

Exclusion criteria

Exclusion criteria: 1. Patients with severe perforation and deformation of the joint disc, unable to establish stable occlusion in the entire mouth. 2. Patients with radiation-induced osteomyelitis, acute or chronic osteomyelitis, or severe osteoporosis. 3. Patients with acute or chronic infections in the TMJ area, a history of trauma, rheumatoid arthritis, or other autoimmune diseases, and any other history of diseases that may affect jawbone growth and development. 4. Patients who have previously undergone temporomandibular joint surgery. 5. Patients with a follow-up period of less than 6 months.

Design outcomes

Primary

MeasureTime frame
Condylar height ;Joint space;Mandibular deviation;Mandibular retrognathia;

Countries

China

Contacts

Public ContactPing Zhang

The Affiliated Stomatological Hospital of Nanjing Medical University

zpnjmu@163.com+86 159 5187 1313

Outcome results

None listed

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