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

Not Applicable

Completed

• Conditions: Temporomandibular Joint Disorders
• Interventions: Device: inactive Laser therapy; Device: anterior re-positioning splint; Device: Laser therapy

• Registration Number: NCT03576079
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2015-09-01
• Primary Completion: 2017-09-30
• Study Completion: 2018-06-01
• Study First Submitted: 2018-06-09
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-02
• Last Update Submitted: 2018-07-02
• Study First Posted: 2018-07-03
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
inactive laser therapy	inactive Laser therapy	placebo laser for 12 sessions over 3 months
anterior re-positioning splint therapy	anterior re-positioning splint	anterior re-positioning splint worn for 8 hours during night time for 3 months
Laser therapy	Laser therapy	12 laser sessions over 3 months

Primary Outcome Measures

Name	Time	Method
Level of temporomandibular joint pain: assessed by using subjective visual analogue scale	3 months	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

Secondary Outcome Measures

Name	Time	Method
click: joint sound	3 months	joint sound., it is a binary measurement assessed by hand palpation
disc recapture	3 months	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
limitation of mandibular movements	3 months	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.