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NCT Number: NCT07698678

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

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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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

Cairo University

Cairo, 0020, Egypt

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. patient pain

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2026
Registry last updated
Jul 14, 2026

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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