Patient-Specific Guides for Gap Pediatric Arthroplasty

NCT07320911 | Active Not Recruiting

• 1 other identifier: 20-12-25/Artho-Tmj
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Ankylosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• accuracy of the guide

  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 Outcomes (1)

• mouth opening

  2 months

Study Arms (1)

Patient-Specific Narrow-Slit Osteotomy Guides for Gap Arthroplasty

EXPERIMENTAL

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

Device: Patient-Specific Narrow-Slit Osteotomy Guides

Interventions

Patient-Specific Narrow-Slit Osteotomy Guides DEVICE

Patient-Specific Narrow-Slit Osteotomy Guides for gap arthroplasty

Patient-Specific Narrow-Slit Osteotomy Guides for Gap Arthroplasty

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Fibrous ankylosis without bony involvement
• Associated craniofacial syndromes
• Patients with systemic conditions contraindicating surgery

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

Location

MeSH Terms

Conditions

Temporomandibular ankylosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2025
• Primary Completion: July 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)