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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Orthodontic Treatment

Intervention / Treatment
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* Radiation: Laser Irradiation One dose
* Radiation: Laser Irradiation Two doses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Irradiation One Dose<br>Laser irradiation will be applied in one dose for patients in this group, but only on one side of the jaw. The other side of the jaw will receive a placebo procedure (i.e. a red light beam will be emitted on the gingival tissues as if they are irradiated by a laser beam). | Radiation: Laser Irradiation One dose<br> <br> |
| Experimental: Laser Irradiation Two doses<br>Laser irradiation will be applied in two doses for patients in this group, but only on one side of the jaw. The second dose will be given after 24 hour of the first one. The other side of the jaw will receive a placebo procedure (i.e. a red light beam will be emitted on the gingival tissues as if they are irradiated by a laser beam). | Radiation: Laser Irradiation Two doses<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Perception | Pain assessment will be performed using a Visual Analog Scale (VAS). | Pain will be evaluated at 1, 6, 24, 48, and 72 hours after laser irradiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low level laser therapy, Elastomeric separator, Placebo, Visual analog scale, Laser irradiation