Patient-Specific Guides for Gap Pediatric Arthroplasty

Alexandria University

Status: Active, not recruiting

Conditions: Temporomandibular Joint Ankylosis

Treatments: Device: Patient-Specific Narrow-Slit Osteotomy Guides

Study type: Interventional

Funder types: Other

Identifiers

NCT07320911

20-12-25/Artho-Tmj

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: Under 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patient with TMJ ankylosis.
2. less than 15 years old at the time of surgery

Exclusion criteria

1. Fibrous ankylosis without bony involvement
2. Associated craniofacial syndromes
3. Patients with systemic conditions contraindicating surgery

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Patient-Specific Narrow-Slit Osteotomy Guides for Gap Arthroplasty

Experimental group

Description:

Pediatric patient with TMJ Ankylosis managed with Patient-Specific Narrow-Slit Osteotomy Guides

Treatment:

Device: Patient-Specific Narrow-Slit Osteotomy Guides