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

January 27, 2017 updated by: University of Colorado, Denver
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado, Pediatric Dental Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No treatment to be rendered following separator placement.
Placebo Comparator: 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).
Other: 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).
Experimental: Treatment
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.
Other Names:
  • Regulatory Class: II
  • Epic 10 Diode Laser by Biolase Inc. (Irvine, CA)
  • Product Code: GEX,ILY
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain experienced by the patient
Time Frame: 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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Children's Hospital Colorado

Investigators

  • Principal Investigator: Linda Murzyn-Dantzer, DMD,MS, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

August 5, 2014

First Submitted That Met QC Criteria

August 6, 2014

First Posted (Estimate)

August 7, 2014

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 13-3091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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