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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05377593
Enrollment
14
Registered
2022-05-17
Start date
2022-03-23
Completion date
2024-06-01
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Dislocation of Temporomandibular Joint (Disorder)

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.

Interventions

DEVICEeminoplasty with patient specific Zirconium dioxide onlay implant

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 48 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Difference in Maximal inter incisal distance between pre-operative and post-operative (mm)6 monthsusing a caliper the difference between preoperative and postoperative Maximal interincisal opening is recorded (mm)

Secondary

MeasureTime frameDescription
Patient's Pain6 monthsin terms of visual analogue scale (0-10)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026