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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-10-31

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.

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Detailed Description

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Conditions

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Levels of Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

No treatment to be rendered following separator placement.

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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).

Treatment

Single blind laser treatment (the laser will be positioned and operated, and energy transfer will take place).

Group Type EXPERIMENTAL

Epic 10 Diode Laser by Biolase Inc.

Intervention Type DEVICE

Interventions

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Epic 10 Diode Laser by Biolase Inc.

Intervention Type DEVICE

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).

Intervention Type OTHER

Other Intervention Names

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Epic 10 Diode Laser by Biolase Inc. (Irvine, CA) Product Code: GEX,ILY Regulatory Class: II 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.

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)

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes