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

NCT02211547 | Withdrawn DMC

• 1 other identifier: 13-3091
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Levels of Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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).

Other: Placebo

Treatment

EXPERIMENTAL

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.

Interventions

Epic 10 Diode Laser by Biolase Inc. DEVICE

Also known as: 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.

Treatment

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).

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Children's Hospital Colorado: collaborator

Study Sites (1)

Children's Hospital Colorado, Pediatric Dental Center

Aurora, Colorado, 80045, United States

Location

Study Officials

• Linda Murzyn-Dantzer, DMD,MS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 7, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

US (1)