An interventional study of Laser therapy and anterior re-positioning splint in Temporomandibular Joint Disorders, sponsored by Cairo University. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-03.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
621 studies on the registry are indexed under Temporomandibular Joint Disorders; 161 are open to participants now.
This study's enrollment of 30 is below the median of 46 across 439 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
12 laser sessions over 3 months
Device: Laser therapy
anterior re-positioning splint worn for 8 hours during night time for 3 months
Device: anterior re-positioning splint
placebo laser for 12 sessions over 3 months
Device: inactive Laser therapy
epic model biolase with an output of 4W, 1800 J wavelength with a continuous Laser mode.
Also known as: low-level Laser therapy, Biolase laser device
hard acrylic anterior re-positioning splint
Also known as: occlusal splint, TMD splint
sham Laser, with inactive beam
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
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Temporomandibular Joint Disorders →