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Clinical Trials/NCT05377593
NCT05377593
Completed
Not Applicable

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

Cairo University1 site in 1 country14 target enrollmentStarted: March 23, 2022Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
14
Locations
1
Primary Endpoint
Difference in Maximal inter incisal distance between pre-operative and post-operative (mm)

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 48 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Difference in Maximal inter incisal distance between pre-operative and post-operative (mm)

Time Frame: 6 months

using a caliper the difference between preoperative and postoperative Maximal interincisal opening is recorded (mm)

Secondary Outcomes

  • Patient's Pain(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Adham Zakaria

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

Cairo University

Study Sites (1)

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