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

N/AActive Not RecruitingNCT07698678

Cairo University20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Recurrent Dislocation of Temporomandibular Joint (Disorder)

Interventions

Eminoplasty with patient specific ultrahigh molecular weight polyethylene onlay implantDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 48 Years

Medical Language ↔ Plain English

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

Locations (1)

Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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