Effect of Low Level Laser Therapy on Pain Induced by Placement of Orthodontic Separators in Pediatric Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Low Level Laser Therapy on Pain Induced by Placement of Orthodontic Separators in Pediatric Patients

Conditions
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Levels of Pain

Intervention / Treatment
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* Device: Epic 10 Diode Laser by Biolase Inc.
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Absence of acute or chronic dental disease and periodontal disease Free from severe systemic disease No fixed orthodontic appliances currently placed No ankylosis or tooth implants within dentition No analgesic drug consumption for 48 hours preceding the study and during the study, a minimum age of 6 years Exclusion Criteria: Presence of a diastema where the separator would be placed Conditions that could alter nociception, such as current or previous use of anti-inflammatory and analgesic drugs, antidepressants, anticonvulsants, and oral contraceptives Any medical conditions or medications that may contraindicate use of certain light/laser sources such as low level laser therapy (LLLT)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No treatment to be rendered following separator placement. | |
| Placebo Comparator: Placebo<br>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<br>* 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).<br>|
| Experimental: Treatment<br>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.<br> <br> * Other names: Number: K121286, with an InGaAsP diode, frequency of 50 Hz, wavelength of 940 nm, and output potency of 10 watts.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 hours |