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

Levels of Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02211547
• Other study ID #: 13-3091
• Status: Withdrawn
• Phase: N/A
• First received: August 5, 2014
• Last updated: January 27, 2017
• Start date: August 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Levels of Pain

Intervention

Device:
• Epic 10 Diode Laser by Biolase Inc.

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).

Locations

Country	Name	City	State
United States	Children's Hospital Colorado, Pediatric Dental Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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