Evaluation of Using Patient Specific Ultra-High Molecular Weight Polyethylene Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation A Randomized Control Trial

July 7, 2026 updated by: Ahmed Tarek Taher Abd El Halim, Cairo University
Does patient specific Ultra-High Molecular Weight Polyethylene implant eminoplasty will decrease maximum interincisal distance, provide better soft tissue response and post-operative patient satisfaction than patient specific Titanium eminoplasty in treatment of chronic condylar dislocation?

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 0020
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with recurrent dislocation with their maximum inter incisal opening over 55mm
  • longstanding dislocation of the TMJ involving both fixation for more than 3weeks and the failure of manual reduction
  • failure of conservative strategies such as orientation to self-limiting jaw movement and the use of chin-cap or bandage

Exclusion Criteria:

  • patients with 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Eminoplasty with patient specific ultrahigh molecular weight polyethylene onlay implant
Eminoplasty will be done for patient with chronic condylar dislocation using specific ultrahigh molecular weight polyethylene implants
Device: Eminoplasty with patient specific ultrahigh molecular weight polyethylene onlay implant
Eminoplasty will be done for patient with chronic condylar dislocation using patient specific ultrahigh molecular weight polyethylene
Active Comparator: eminoplasty with patient specific titanium onlay implant
Device: Eminoplasty with patient specific ultrahigh molecular weight polyethylene onlay implant
Eminoplasty will be done for patient with chronic condylar dislocation using patient specific ultrahigh molecular weight polyethylene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in maximal inter incisal distance between pre-operative and post-operative (mm)
Time Frame: 6 months
using a caliper difference between preoperative and postoperative maximal interincisal opening is recorded (mm)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient pain
Time Frame: 6 months
IN terms of visual analogue scale (0-10)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2024

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • OMFS3-3-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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