Effect of Laser Therapy Versus Anterior Re-positioning Splint in the Treatment of Disc Displacement With Reduction

Cairo University30 enrolled

Overview

comparing the effects of Laser therapy with anterior re-positioning splint and a placebo group on clinical signs and symptoms of temporo-mandibular dis-function and assessing articular disc morphology and configuration with magnetic resonance imaging.

to compare the clinical effects of Laser therapy as assessed with research diagnostic criteria of temporo-mandibular disorders to a group that received anterior re-positioning splint therapy and a control group that received placebo Laser. Diagnosis for disc displacement with reduction was performed with magnetic resonance imaging before treatment. assessment of the clinical and MRI findings was again performed after a 3 months observation period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Temporomandibular Joint Disorders

Interventions

Laser therapyDEVICE

epic model biolase with an output of 4W, 1800 J wavelength with a continuous Laser mode.

anterior re-positioning splintDEVICE

hard acrylic anterior re-positioning splint

inactive Laser therapyDEVICE

sham Laser, with inactive beam

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients having TMD in the form of disc displacement with reduction as verified from signs and symptoms during clinical examination and confirmed from the MRI. 2. Good general health: The patient must be medically free from any systemic disease or health problems. 3. Adult patients 18 years old and above. 4. No previous orthodontic treatment. 5. No previous TMJ treatment or surgery. Exclusion Criteria: 1. Patients with multiple missing posterior teeth. 2. Muscle pain due to systemic disease. 3. Dental related pain. 4. Congenital abnormality, neoplasia or acute trauma. 5. Previous TMJ treatment or surgery. 6. Any medical condition that prohibits MRI acquisition.

Outcomes

Primary Outcomes

Level of temporomandibular joint pain: assessed by using subjective visual analogue scale

current level of temporomandibular joint pain assessed by using subjective visual analogue scale from 1 to 10 according to the research diagnostic criteria of temporomandibular disorders diagnostic sheets, zero indicates no pain, while 10 indicates the worst pain

Time frame: 3 months

Secondary Outcomes

click: joint sound

joint sound., it is a binary measurement assessed by hand palpation

Time frame: 3 months

limitation of mandibular movements

mouth opening, measured between the incisal edges of upper and lower incisors using a digital caliper, right and left mandibular movements, measured from upper dental midline to lower dental midline using a digital caliper.

Time frame: 3 months

disc recapture

change in articular disc morphology and configuration using two dimensional measurements on a DICOM viewer software including both linear and angular measurements in relation to cartesian coordinates X and Y

Time frame: 3 months

Data from ClinicalTrials.gov

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