Evolving Treatment Modalities for Management of Patients Suffering From Disc Displacement With Reduction

N/ACompletedNCT05194488

Nourhan M.Aly27 enrolled

Overview

Aim of the current study is to compare the efficacy of Low Level Laser, Botulinum toxin type A, and repositioning appliance in management of reduced temporomandibular joint disc.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Temporomandibular Joint Disc Displacement, With Reduction

Interventions

Low level laser therapyDEVICE

Patients will receive low-level laser therapy on the temporomandibular joint disc

Botulinum toxin type ADRUG

Patients will receive Botulinum toxin type A injection into the lateral pterygoid muscle under Electromyography (EMG) guidance.

Anterior repositioning applianceDEVICE

Patients will receive hard maxillary anterior repositioning appliance.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * TMJ with audible and palpable click. * Patients with anterior disc displacement as detected by MRI. * Presence of full or nearly full complement of natural teeth. Exclusion Criteria: * Patients who have radiographic evidence of degenerative conditions of TMJ. * Patients who have anterior disc dislocation without reduction. * Previous history of TMD treatment. * History of recent trauma. * The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis). * Inability or unwillingness to undergo magnetic resonance imaging (MRI) such as implanted electronic devices. * Pregnant and lactating females. * Patients with known allergy to botulinum toxin type A. * Patients suffering from neurological disorders.

Locations (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

Temporomandibular joint dysfunction

Using Helkimo Anamnestic Index that includes 5 items, each having 3 possible answers scored 0, 1 or 5. The 1st item assesses limitations in range of jaw movement \& is divided to 4 sections: maximum mouth opening, protrusion \& lateral shift. For mouth opening , value of \>40mm scores 0, 30-39mm scores 1 \& \<30mm scores 5. Protrusion \& lateral shifts score 0 if the measurement is ≥7mm, 1 if ranging between 4-6mm and 5 if it is \<4mm. These sections are added together to get a total that scores 0 if the sum of the 4 sections is 0, 1 if the subtotal is between 1-4 \& 5 if the subtotal is \>4. The 2nd item evaluates joint alterations that produce deviations, sounds and joint locks. The 3rd item evaluates pain when performing movements. The 4th item evaluates masticatory muscles pain. The 5th item evaluates pain on palpation in the prearticular area of TMJ. The 5 items are added and scored; 0: no TMJ involvement, 1-9: mild involvement, 10-19: moderate involvement \& 20-25: severe involvement

Time frame: 3 months

Pain level

This will be assessed using the visual analogue scale (VAS) with score ranges from 0 (lowest) to 10 (highest). Higher scores indicate greater pain levels.

Time frame: 3 months

Temporomandibular joint clinical evaluation

Magnetic Resonance Imaging (MRI) will be performed for all patients using a 3 Tesla MRI scanner with a head coil. Gradient T2 (T2\*) and proton-density (PD) weighted spin echo (SE) sequences will be carried out in closed and open mouth positions in the oblique sagittal plane. MRI is considered the gold standard (objective) in imaging the soft tissue components of the TMJ.

Time frame: 3 months

Data from ClinicalTrials.gov

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