Evaluation of Using Patient Specific Zirconium Dioxide Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation

Study Overview
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Brief Summary
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Alternate hypothesis that treatment of Tempromandibular joint dislocation with Zirconium Dioxide eminoplasty will be more efficient than using titanium onlays in terms of decreasing maximum inter incisal distance and providing better soft tissue response and post-operative patient satisfaction.

Official Title
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Evaluation of Using Patient Specific Zirconium Dioxide Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation. A Randomized Clinical Trial

Conditions
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Recurrent Dislocation of Temporomandibular Joint (Disorder)

Intervention / Treatment
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* Device: eminoplasty with patient specific Zirconium dioxide onlay implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with recurrent dislocation with maximum inter incisal opening over 55mm Long-standing dislocation of the TMJ involving both fixation for more than 3 weeks and the failure of manual reduction Failure of conservative strategies such as orientation to self-limit jaw movement and the use of a chin-cap or bandage Both sexes Age between 18 and 48 years. Highly motivated patients. Exclusion Criteria: Post-menopausal females with osteoporosis Patient with uncontrolled systemic disease pregnancy psychological disorders, drug or alcohol dependency Known allergies or sensitivities to dental materials, including Zirconia, Titanium or general anesthetic agents Inability to return for follow up visits. Refusal of participation from the patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Randomized Clinical Trial A Trial will be carried out in hospital of Oral and Maxillofacial Surgery department- Faculty of dentistry Cairo University. Equal Randomization: Participants receiving treatment. Positive Controlled: Both groups receiving treatment. Parallel group study: each group of patients receives single treatment simultaneously.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: eminoplasty with patient specific Titanium onlay implant<br> | Device: eminoplasty with patient specific Zirconium dioxide onlay implant<br>* Eminoplasties will be done for patient with chronic condylar dislocation using patient specific zirconium dioxide implants<br>|
| Active Comparator: eminoplasty with patient specific zirconium dioxide onlay implant<br> | Device: eminoplasty with patient specific Zirconium dioxide onlay implant<br>* Eminoplasties will be done for patient with chronic condylar dislocation using patient specific zirconium dioxide implants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Maximal inter incisal distance between pre-operative and post-operative | using a caliper the difference between preoperative and postoperative Maximal interincisal opening is recorded (mm) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Questioning the patient about if there is any dislocation or any limitation to mandibular movement (yes/no) | 6 months |