Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07320911

Patient-Specific Guides for Gap Pediatric Arthroplasty

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Temporomandibular Joint Ankylosis Temporomandibular ankylosis

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-Specific Narrow-Slit Osteotomy Guides

Device

Patient-Specific Narrow-Slit Osteotomy Guides for gap arthroplasty

Primary outcomes

  1. 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

  1. mouth opening

    Time frame: 2 months

    inter-arch mouth opening assessment

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.