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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02211547

Enrollment

Registered

2014-08-07

Start date

2014-08-31

Completion date

2015-10-31

Last updated

2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Levels of Pain

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.

Interventions

DEVICEEpic 10 Diode Laser by Biolase Inc.

OTHERPlacebo

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).

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Pain experienced by the patient	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026