Patient-Specific Guides for Gap Pediatric Arthroplasty

December 20, 2025 updated by: Alexandria University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Alexandria Governorate
      • Alexandria, Alexandria Governorate, Egypt, 21523
        • Faculty of Dentistry, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient-Specific Narrow-Slit Osteotomy Guides for Gap Arthroplasty
Pediatric patient with TMJ Ankylosis managed with Patient-Specific Narrow-Slit Osteotomy Guides
Device: Patient-Specific Narrow-Slit Osteotomy Guides
Patient-Specific Narrow-Slit Osteotomy Guides for gap arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mouth opening
Time Frame: 2 months
inter-arch mouth opening assessment
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

July 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 20, 2025

First Submitted That Met QC Criteria

December 20, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 20, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-12-25/Artho-Tmj

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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