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Completed

NCT Number: NCT02209818

Effect of Laser Application in Pain Management Following the Use of Orthodontic Elastomeric Separators

The aim of this study is to evaluate the effect of low level laser therapy (LLLT) on pain management in people commencing orthodontic treatment. The study design is a randomized controlled trial.

Participants' pain will be dealt with by laser irradiation in one side of the jaw randomly, and the other side will be treated by a placebo procedure. Pain assessment will be measured using Visual Analog Scales (VAS).

The hypothesis of this study is that laser irradiation decreases the amount of pain following the insertion of orthodontic separators.

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Key information

Conditions

Orthodontic Treatment

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, DM20AM18, Syria

About this study

Here we have two groups:

The first group will undergo one dose of irradiation which is going to be applied on one side of the mouth whereas the opposing side will serve as a control side (placebo).

The second group will undergo two doses of irradiation which is going to be applied on one side of the mouth whereas the opposing side will serve as a control side (placebo).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants should have healthy periodontal structures, healthy teeth.
  • Presence of first molar in both side of the jaw.

Exclusion criteria

  • systemic diseases
  • chronic pain or neurological pain

Treatment and study plan

Laser Irradiation One dose

Radiation

Laser Irradiation Two doses

Radiation

Primary outcomes

  1. Change in Pain Perception

    Time frame: Pain will be evaluated at 1, 6, 24, 48, and 72 hours after laser irradiation

    Pain assessment will be performed using a Visual Analog Scale (VAS).

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of Low Level Laser Therapy (LLLT) Effect on Pain Management Caused by Orthodontic Elastomeric Separators

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Aug 6, 2014
Registry last updated
Mar 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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