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

NCT07698678 | Completed

• 1 other identifier: OMFS3-3-4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Recurrent Dislocation of Temporomandibular Joint (Disorder)

Outcome Measures

Primary Outcomes (1)

• Difference in maximal inter incisal distance between pre-operative and post-operative (mm)

  using a caliper difference between preoperative and postoperative maximal interincisal opening is recorded (mm)

  6 months

Secondary Outcomes (1)

• patient pain

  6 months

Study Arms (2)

Eminoplasty with patient specific ultrahigh molecular weight polyethylene onlay implant

ACTIVE COMPARATOR

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 with patient specific titanium onlay implant

ACTIVE COMPARATOR

eminoplasty with patient specific titanium onlay implant

Device: Eminoplasty with patient specific ultrahigh molecular weight polyethylene onlay implant

Interventions

Eminoplasty with patient specific ultrahigh molecular weight polyethylene onlay implant DEVICE

Eminoplasty will be done for patient with chronic condylar dislocation using patient specific ultrahigh molecular weight polyethylene

Eminoplasty with patient specific ultrahigh molecular weight polyethylene onlay implant; eminoplasty with patient specific titanium onlay implant

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 0020, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant at Oral and Maxillofacial Surgery department, Faculty of dentistry

Model Details: A Randomized clinical trial A trial will 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.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: July 6, 2024
• Primary Completion: September 15, 2026
• Study Completion: September 15, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)