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

NCT ID: NCT05377593

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2024-06-01

Brief Summary

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.

Conditions

Recurrent Dislocation of Temporomandibular Joint (Disorder)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

eminoplasty with patient specific Titanium onlay implant

Group Type: ACTIVE_COMPARATOR

eminoplasty with patient specific Zirconium dioxide onlay implant

Intervention Type: DEVICE

Eminoplasties will be done for patient with chronic condylar dislocation using patient specific zirconium dioxide implants

eminoplasty with patient specific zirconium dioxide onlay implant

Group Type: ACTIVE_COMPARATOR

eminoplasty with patient specific Zirconium dioxide onlay implant

Intervention Type: DEVICE

Eminoplasties will be done for patient with chronic condylar dislocation using patient specific zirconium dioxide implants

Interventions

eminoplasty with patient specific Zirconium dioxide onlay implant

Eminoplasties will be done for patient with chronic condylar dislocation using patient specific zirconium dioxide implants

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Adham Zakaria

Teaching Assistant at Oral and Maxillofacial Sugery department, Faculty of dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed Kadry Nasr, Doctorate

Role: STUDY_DIRECTOR

Lecturer at Oral and Maxillofacial Surgery department, Faculty of dentistry, Cairo University

Locations

Adham Zakaria

Cairo, , Egypt

Countries

Egypt

Other Identifiers

OMFS 3-3-4

Identifier Type: -

Identifier Source: org_study_id