An interventional study of Epic 10 Diode Laser by Biolase Inc. and Placebo in Levels of Pain, sponsored by University of Colorado, Denver. Withdrawn at 1 site in United States. Open to participants aged 6 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-31.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
The primary goal of the study is to determine if there is a difference in pain levels following the use of low level laser therapy versus placebo and control after placement of elastomeric orthodontic separators in pediatric patients. To test this, the investigators will assess the patient's pain levels immediately following separator placement and 24 hours post-operatively but having patients rate their pain on a 10 cm Visual Analog Scale (VAS). Patients will be randomly assigned to one of three groups: treatment, placebo, and control. The aim of this study is to establish whether or not low level laser therapy can be used to reduce pain in pediatric patients following separator placement.
University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 318 are open to participants now.
Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Exclusion Criteria:
No treatment to be rendered following separator placement.
Single blind lack of laser treatment (the laser will be positioned and operated as if applying the treatment, but the energy transfer will not take place).
Other: Placebo
Single blind laser treatment (the laser will be positioned and operated, and energy transfer will take place).
Device: Epic 10 Diode Laser by Biolase Inc.
Also known as: Epic 10 Diode Laser by Biolase Inc. (Irvine, CA), Product Code: GEX,ILY, Regulatory Class: II, Regulation number: 878.4810, 510(K), Number: K121286, with an InGaAsP diode, frequency of 50 Hz, wavelength of 940 nm, and output potency of 10 watts.
Single blind lack of laser treatment (the laser will be positioned and operated as if applying the treatment, but the energy transfer will not take place).
Pain experienced by the patient
Pain will be assessed via a 10 cm non-hashed visual analog scale at two time points, immediately after placement of the elastomeric separators (time 0), and approximately 24 hours after placement when the patient returns to the clinic for separator removal.
Time frame: 24 hours
The record gives a start of Aug 2014, a primary completion of Jun 2015 and a completion of Oct 2015. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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