Clinical Trials Directory

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Active Not RecruitingNCT07320911

Patient-Specific Guides for Gap Pediatric Arthroplasty

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
8 (actual)
Sponsor
Alexandria University · Academic / Other
Sex
All
Age
15 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEPatient-Specific Narrow-Slit Osteotomy GuidesPatient-Specific Narrow-Slit Osteotomy Guides for gap arthroplasty

Timeline

Start date
2025-01-01
Primary completion
2025-07-30
Completion
2025-12-31
First posted
2026-01-06
Last updated
2026-01-06

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07320911. Inclusion in this directory is not an endorsement.