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

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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Dislocation of Temporomandibular Joint (Disorder)
• Intervention / Treatment: Device: eminoplasty with patient specific Zirconium dioxide onlay implant

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Adham Zakaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Maximal inter incisal distance between pre-operative and post-operative (mm)	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's Pain	in terms of visual analogue scale (0-10)	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Mohammed Kadry Nasr, Doctorate, Lecturer at Oral and Maxillofacial Surgery department, Faculty of dentistry, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 2, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations
• Other Study ID Numbers: OMFS 3-3-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No