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

Not Applicable

Withdrawn

• Conditions: Levels of Pain
• Interventions: Other: Placebo; Device: Epic 10 Diode Laser by Biolase Inc.

• Registration Number: NCT02211547
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-05
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-07
• Primary Completion: 2015-06
• Study Completion: 2015-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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).
Treatment	Epic 10 Diode Laser by Biolase Inc.	Single blind laser treatment (the laser will be positioned and operated, and energy transfer will take place).

Primary Outcome Measures

Name	Time	Method
Pain experienced by the patient	24 hours	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.

Trial Locations

Locations (1)

Children's Hospital Colorado, Pediatric Dental Center; 🇺🇸 Aurora, Colorado, United States