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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07698678
Enrollment
20
Registered
2026-07-13
Start date
2024-07-06
Completion date
2026-09-15
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Dislocation of Temporomandibular Joint (Disorder)

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?

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 48 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Difference in maximal inter incisal distance between pre-operative and post-operative (mm)6 monthsusing a caliper difference between preoperative and postoperative maximal interincisal opening is recorded (mm)

Secondary

MeasureTime frameDescription
patient pain6 monthsIN 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026