Virtual Planning of Total TMJ Replacement

NCT07643259 — Not applicable, Completed, 8 participants, Faculty of Dental Medicine for Girls

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

Registry	NCT07643259, acronym TJR
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	8 (Actual)
Sponsor	Faculty of Dental Medicine for Girls (Other gov)
Conditions	TMJ Disorder, Mandibular Deficiency, TMJ Ankylosis
Interventions	Custom made TMJ (Device)
Dates	start 2023-08-01, primary completion 2026-03-02, completion 2026-05-24, first posted 2026-06-11, last updated 2026-06-11
Locations	1 site in Egypt

-Summary

Virtual Planning of Total TMJ Replacement

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+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
Total Joint replacement using Virtual planned custom made joint	Experimental	Device: Custom made TMJ	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.

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

+Outcome measures

Primary outcomes

Accuracy of the Virtually planned TMJ [3 days postoperative]: superimposition of the postoperative and preoperative instructions using CT calculating Linear deviation (mm) to assess surgical accuracy.

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Dent for Girls	Cairo, Nasr City	Egypt

+Investigators

Mahetab Montaser, PhD Cand., Principal investigator, PHD Candidate
susan Hassan, professor, Study chair, professor of oral and maxillofacial surgery
Sara Bahaa, Lecturer, Study director, Lecturer of removable prosthesis at Alazhar university
wael shawkat, PHD, Study director, consultant of Oral and Maxillofacial surgery, Nasr city Hospital for Health Insurance