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CompletedNCT07698678Updated Oct 2, 2026

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

An interventional study of Eminoplasty with patient specific ultrahigh molecular weight polyethylene onlay implant in Recurrent Dislocation of Temporomandibular Joint (Disorder), sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 48 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Jul 2024, registered Jul 2026).
Updated Oct 2, 2026Now Completed1 site added+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 48 Years
Sex
All
01

Study 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?

02

Conditions studied

  • Recurrent Dislocation of Temporomandibular Joint (Disorder)
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 48 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • 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

  • Active comparator
    eminoplasty with patient specific titanium onlay implant

    eminoplasty with patient specific titanium onlay implant

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

Interventions

  • DeviceEminoplasty 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

06

What researchers measure

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)

    Time frame: 6 months

Secondary outcomes

  1. patient pain

    IN terms of (VAS) visual analogue scale (0-10), Visual Analog Scale (VAS) is a 0-10 scale used to measure pain intensity, where 0 represents no pain and 10 represents the worst possible pain.The Visual Analog Scale (VAS) is a validated, subjective tool for assessing pain intensity in both acute and chronic conditions. It consists of a continuous line, usually 10 cm (100 mm) long, anchored at one end with "no pain" (0) and at the other end with "worst imaginable pain" (10). Patients indicate their pain by marking a point along the line that best represents their current pain level. The distance from the "no pain" end is measured in centimeters or millimeters to quantify pain intensity 0: No pain,1-3: Mild pain, usually tolerable and not interfering significantly with daily activity, 4-6: Moderate pain, noticeable and may limit some activities,7-9: Severe pain, significantly limiting daily activities and requiring intervention,10: Worst possible pain, unbearable need urgent management

    Time frame: 6 months

07

Study locations

1 site
  • Cairo University
    Cairo, Cairo Governorate 0020, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Oct 2, 2026
Sites
1 site added, 1 site removed
Show site
  • Cairo University · Cairo, Egypt
Show 1 removed
  • Cairo University · Cairo, Egypt
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Active, not recruiting→Completed
    1 site added, 1 site removed
    Show site
    • Cairo University · Cairo, Egypt
    Show 1 removed
    • Cairo University · Cairo, Egypt
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07698678
Lead sponsor
Cairo University
Responsible party
Ahmed Tarek Taher Abd El Halim (Teaching Assistant at Oral and Maxillofacial Surgery department, Faculty of dentistry, Cairo University) — Principal investigator
First posted
Jul 13, 2026
Start date
Jul 6, 2024
Primary completion
Sep 15, 2026
Completion
Sep 15, 2026
Last update
Oct 2, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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