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

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ClinicalTrials.gov Identifier: NCT03576079
Recruitment Status : Completed
First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Nada Elzawahry, Cairo University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Device: Laser therapy Device: anterior re-positioning splint Device: inactive Laser therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Laser Irradiation Versus Anterior Repositioning Splint in Treatment of Disc Displacement With Reduction A Randomized Controlled Clinical Trial
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Laser therapy
12 laser sessions over 3 months
 Device: Laser therapy
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
Active Comparator: anterior re-positioning splint therapy
anterior re-positioning splint worn for 8 hours during night time for 3 months
 Device: anterior re-positioning splint
hard acrylic anterior re-positioning splint
Other Names:
  • occlusal splint
  • TMD splint
Placebo Comparator: inactive laser therapy
placebo laser for 12 sessions over 3 months
 Device: inactive Laser therapy
sham Laser, with inactive beam


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03576079


Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Mona S Fayed, PHD Professor of Orthodontics, Faculty of Dentistry, Cairo Universitye
More Information
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Responsible Party: Nada Elzawahry, assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03576079    
Other Study ID Numbers: CEBD-CU-2015-02-25
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Nada Elzawahry, Cairo University:
laser therapy
anterior re-positioning splint
Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
 Stomatognathic Diseases
Myofascial Pain Syndromes
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents