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OpenTrials
Completed

NCT Number: NCT03576079

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

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.

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Key information

Conditions

Temporomandibular Joint Disorders Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Good general health: The patient must be medically free from any systemic disease or health problems.
  • Adult patients 18 years old and above.
  • No previous orthodontic treatment.
  • No previous TMJ treatment or surgery.

Exclusion criteria

  • Patients with multiple missing posterior teeth.
  • Muscle pain due to systemic disease.
  • Dental related pain.
  • Congenital abnormality, neoplasia or acute trauma.
  • Previous TMJ treatment or surgery.
  • Any medical condition that prohibits MRI acquisition.

Treatment and study plan

Laser Therapy

Device

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

Other names: low-level Laser therapy, Biolase laser device

anterior re-positioning splint

Device

hard acrylic anterior re-positioning splint

Other names: occlusal splint, TMD splint

inactive Laser therapy

Device

sham Laser, with inactive beam

Primary outcomes

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

    Time frame: 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 outcomes

  1. click: joint sound

    Time frame: 3 months

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

  2. limitation of mandibular movements

    Time frame: 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.

  3. disc recapture

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Laser Irradiation Versus Anterior Repositioning Splint in Treatment of Disc Displacement With Reduction A Randomized Controlled Clinical Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jul 3, 2018
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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