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

NCT05377593 | Completed

• 1 other identifier: OMFS 3-3-4
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient's Pain

  6 months

Study Arms (2)

eminoplasty with patient specific Titanium onlay implant

ACTIVE COMPARATOR

Device: eminoplasty with patient specific Zirconium dioxide onlay implant

eminoplasty with patient specific zirconium dioxide onlay implant

ACTIVE COMPARATOR

Device: eminoplasty with patient specific Zirconium dioxide onlay implant

Interventions

eminoplasty with patient specific Zirconium dioxide onlay implant DEVICE

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

eminoplasty with patient specific Titanium onlay implant; eminoplasty with patient specific zirconium dioxide onlay implant

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Adham Zakaria

Cairo, Egypt

Location

Study Officials

• Mohammed Kadry Nasr, Doctorate

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant at Oral and Maxillofacial Sugery department, Faculty of dentistry

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 17, 2022
• Study Start: March 23, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

EG (1)