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

University of Colorado, Denver

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Levels of Pain

Interventions

Epic 10 Diode Laser by Biolase Inc.DEVICE

PlaceboOTHER

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).

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Children's Hospital Colorado, Pediatric Dental Center

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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