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| Name | Class |
|---|---|
| Children's Hospital Colorado | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No treatment to be rendered following separator placement. | |
| Placebo | Placebo Comparator | 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). |
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| Treatment | Experimental | Single blind laser treatment (the laser will be positioned and operated, and energy transfer will take place). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epic 10 Diode Laser by Biolase Inc. | Device |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Murzyn-Dantzer, DMD,MS | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado, Pediatric Dental Center | Aurora | Colorado | 80045 | United States |
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| Placebo | Other | 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). |
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