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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05377593

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Dislocation of Temporomandibular Joint (Disorder)	Device: eminoplasty with patient specific Zirconium dioxide onlay implant	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Masking Description:

Because the two interventions used in this trial are clearly different and easily recognized by the participants and investigators. neither the investigators nor the participants can be blinded.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 23, 2022

Anticipated Primary Completion Date :

Jan 23, 2023

Anticipated Study Completion Date :

Mar 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: eminoplasty with patient specific Titanium onlay implant	Device: eminoplasty with patient specific Zirconium dioxide onlay implant Eminoplasties will be done for patient with chronic condylar dislocation using patient specific zirconium dioxide implants
Active Comparator: eminoplasty with patient specific zirconium dioxide onlay implant	Device: eminoplasty with patient specific Zirconium dioxide onlay implant Eminoplasties will be done for patient with chronic condylar dislocation using patient specific zirconium dioxide implants

Arm

Intervention/Treatment

Active Comparator: eminoplasty with patient specific Titanium onlay implant

Device: eminoplasty with patient specific Zirconium dioxide onlay implant

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

Active Comparator: eminoplasty with patient specific zirconium dioxide onlay implant

Device: eminoplasty with patient specific Zirconium dioxide onlay implant

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

Outcome Measures

Primary Outcome Measures

Difference in Maximal inter incisal distance between pre-operative and post-operative [6 months]
using a caliper the difference between preoperative and postoperative Maximal interincisal opening is recorded (mm)

Secondary Outcome Measures

Patient satisfaction [6 months]
Questioning the patient about if there is any dislocation or any limitation to mandibular movement (yes/no)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 48 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adham Zakaria	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Study Director: Mohammed Kadry Nasr, Doctorate, Lecturer at Oral and Maxillofacial Surgery department, Faculty of dentistry, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adham Zakaria, Teaching Assistant at Oral and Maxillofacial Sugery department, Faculty of dentistry, Cairo University

ClinicalTrials.gov Identifier:

NCT05377593

Other Study ID Numbers:

OMFS 3-3-4

First Posted:

May 17, 2022

Last Update Posted:

May 17, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Joint Dislocations

Study Results

No Results Posted as of May 17, 2022