Patient-Specific Narrow-Slit Osteotomy Guides for Gap Arthroplasty in Pediatric TMJ Ankylosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Alexandria University
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- accuracy of the guide
Study Overview
Brief Summary
To date, few reports have combined patient-specific guides with piezoelectric devices for gap arthroplasty in children. This study evaluates the feasibility, accuracy, and early outcomes of this approach, hypothesizing that the combination of narrow-slit surgical guides and piezoelectric osteotomy provides safe and reproducible results in pediatric TMJ ankylosis.
Detailed Description
A prospective pilot study was conducted on [n] children (mean age [x] years) with TMJ ankylosis. Virtual surgical planning and CAD/CAM fabrication were used to design patient-specific guides with narrower osteotomy slits (width [x] mm) to allow precise bone removal and improved condylar fit. Preoperative and postoperative CT scans were superimposed to measure the accuracy of gap creation. Functional outcomes included maximal interincisal opening (MIO) at 1, 3, and 6 months, and complications.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patient with TMJ ankylosis.
- •less than 15 years old at the time of surgery
Exclusion Criteria
- •Fibrous ankylosis without bony involvement
- •Associated craniofacial syndromes
- •Patients with systemic conditions contraindicating surgery
Arms & Interventions
Patient-Specific Narrow-Slit Osteotomy Guides for Gap Arthroplasty
Pediatric patient with TMJ Ankylosis managed with Patient-Specific Narrow-Slit Osteotomy Guides
Intervention: Patient-Specific Narrow-Slit Osteotomy Guides (Device)
Outcomes
Primary Outcomes
accuracy of the guide
Time Frame: 1 week
Follow-up imaging was performed 1 week postoperatively using computed tomography (CT). Digital superimposition of the preoperative virtual plan and postoperative CT scans was carried out to assess the accuracy of osteotomy execution.
Secondary Outcomes
- mouth opening(2 months)