Completed

NCT Number: NCT05377593

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

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.

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Key information

Conditions

Recurrent Dislocation of Temporomandibular Joint (Disorder)

Age range

18 year–48 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adham Zakaria

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Time frame: 6 months

in terms of visual analogue scale (0-10)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: May 17, 2022
Registry last updated: Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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