Virtual Planning of Total TMJ Replacement (TJR)

The Accuracy of Virtual Surgical Planning of Total Custom-fit Tempromandibular Joint Replacement

Virtual Planning of Total TMJ Replacement

Study Overview

• Status: Completed
• Conditions: TMJ Disorder; Mandibular Deficiency; TMJ Ankylosis
• Intervention / Treatment: Device: Custom made TMJ

Detailed Description

This study were performed on eight patients to evaluate the accuracy of virtual planning of the custom planning alloplastic TMJ replacement surgery

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Nasr City
    • Cairo, Nasr City, Egypt, 12345
      • Dent for Girls

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients have a history of end-stage TMJ disorders.
• Patients with mandibular defects involving the TMJ,developmental abnormalities, trauma and, tumor.
• Patients with failed grafts and alloplastic joint reconstruction.
• Patients with recurrent TMJ ankylosis.

Exclusion Criteria:

• Patients with bone disease that can affect stability of the joint.
• Patients with systemic disease, malignancy and immunocompromised patients.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Total Joint replacement using Virtual planned custom made joint; eight patients had been selected randomly according to the inclusion and exclusion criteria. All of them were need total joint replacement for their TMJ. Virtually planned custom-made joints were used. The accuracy of the artificial joints then measured.	Device: Custom made TMJ; Patients with end stage TMJ disorders, Tumors, Recurrent ankylosis, traumaof failed previous joint reconstruction had TMJ total Replacement using custom made TMJ via Virtual planning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the Virtually planned TMJ	superimposition of the postoperative and preoperative instructions using CT calculating Linear deviation (mm) to assess surgical accuracy.	3 days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of artificial joint on electromyographic activity of masticatory muscle	was measured using electromyograph. the parameters were measured through recording Muscle activity during maximum voluntary clenching and at rest.	3 months following up
occlusal force	occlusal force and distribution during clenching using B scan device. Parameters including Maximum occlusal force (%)	3 months following up

Collaborators and Investigators

• Sponsor: Faculty of Dental Medicine for Girls
• Investigators: Principal Investigator: Mahetab Montaser, PhD Cand., PHD Candidate; Study Chair: susan Hassan, professor, professor of oral and maxillofacial surgery; Study Director: Sara Bahaa, Lecturer, Lecturer of removable prosthesis at Alazhar university; Study Director: wael shawkat, PHD, consultant of Oral and Maxillofacial surgery, Nasr city Hospital for Health Insurance

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): March 2, 2026
• Study Completion (Actual): May 24, 2026

Study Registration Dates

• First Submitted: May 31, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Virtual Planning; Total TMJ replacement; End Stage TMJ Disorder
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Craniomandibular Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Temporomandibular Joint Disorders; Micrognathism; Temporomandibular ankylosis
• Other Study ID Numbers: OR SUR-108-2-0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No