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

University of Colorado Denver (CU Denver)

Status: Withdrawn

Conditions: Levels of Pain

Treatments: Other: Placebo; Device: Epic 10 Diode Laser by Biolase Inc.

Study type: Interventional

Funder types: Other

Identifiers

NCT02211547

13-3091

Details and patient eligibility

About

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.

Sex: All

Ages: 6 to 17 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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0 participants in 3 patient groups, including a placebo group

Control

No Intervention group

Description:

No treatment to be rendered following separator placement.

Placebo

Placebo Comparator group

Description:

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:

Other: Placebo

Treatment

Experimental group

Description:

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

Treatment:

Device: Epic 10 Diode Laser by Biolase Inc.