Virtual Planning of Total TMJ Replacement

NCT07643259 | Completed

• 1 other identifier: OR SUR-108-2-0
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Virtual Planning of Total TMJ Replacement

Conditions

TMJ Disorder; Mandibular Deficiency; TMJ Ankylosis

Keywords

Virtual Planning; Total TMJ replacement; End Stage TMJ Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• effect of artificial joint on electromyographic activity of masticatory muscle

  3 months following up

• occlusal force

  3 months following up

Study Arms (1)

Total Joint replacement using Virtual planned custom made joint

EXPERIMENTAL

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

Interventions

Custom made TMJ DEVICE

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

Total Joint replacement using Virtual planned custom made joint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Dent for Girls

Cairo, Nasr City, 12345, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Micrognathism; Temporomandibular ankylosis

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mahetab Montaser, PhD Cand.

  PHD Candidate

  PRINCIPAL INVESTIGATOR

• susan Hassan, professor

  professor of oral and maxillofacial surgery

  STUDY CHAIR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: non applicable
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Oral and Maxillofacial surgery, AlAhram Canadian Uiversity

Model Details: eight patients were treated with alloplastic TMJ replacement using patient custom made joint designed via virtual surgical planning

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 11, 2026
• Study Start: August 1, 2023
• Primary Completion: March 2, 2026
• Study Completion: May 24, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)