Patient-Specific Guides for Gap Pediatric Arthroplasty

Patient-Specific Narrow-Slit Osteotomy Guides for Gap Arthroplasty in Pediatric TMJ Ankylosis

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07320911

Enrollment

Registered

2026-01-06

Start date

2025-01-01

Completion date

2025-12-31

Last updated

2026-01-06

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

Conditions

Temporomandibular Joint Ankylosis

Keywords

TMJ ankylosis, pediatrics, gap arthroplasty, CAD/CAM, surgical guide

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.

Interventions

DEVICEPatient-Specific Narrow-Slit Osteotomy Guides

Patient-Specific Narrow-Slit Osteotomy Guides for gap arthroplasty

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 15 Years

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

Design outcomes

Primary

Measure	Time frame	Description
accuracy of the guide	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

Measure	Time frame	Description
mouth opening	2 months	inter-arch mouth opening assessment

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026