Evaluation of Using Patient Specific Zirconium Dioxide Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation. A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Difference in Maximal inter incisal distance between pre-operative and post-operative (mm)
Study 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
Arms & Interventions
eminoplasty with patient specific Titanium onlay implant
Intervention: eminoplasty with patient specific Zirconium dioxide onlay implant (Device)
eminoplasty with patient specific zirconium dioxide onlay implant
Intervention: eminoplasty with patient specific Zirconium dioxide onlay implant (Device)
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
Adham Zakaria
Teaching Assistant at Oral and Maxillofacial Sugery department, Faculty of dentistry
Cairo University