Laser Therapy on Controlling Pain During Orthondontic Treatment

Study Overview
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Brief Summary
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To evaluate the effectiveness of pain reduction on a initial orthodontic treatment by using 810nm Diode laser compared to a placebo. Methods: This study will include two parallels groups, 30 adult patients each (mean age 18 - 40) that will be asked to fill a questionnaire related with pain before starting orthodontic treatment with Tip edge technique. Patients from one of the groups will receive laser therapy on both upper and lower maxillary according to the protocol. The patients from the other group will receive a placebo simulating a laser therapy on both maxillary. After the process, both groups will be checked on different times (12hrs-24hrs-48hrs-72hrs after) by filling a questionnaire related with pain each time.

Detailed Description
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This is a parallel, double-blind, controlled, single-center clinical trial conducted in systemically healthy subjects requiring orthodontic treatment without extractions at the start of treatment in Bogotá, Colombia. Sixty patients (60) will be randomized in a 1: 1 ratio, to either of the two arms of this trial. This study will consist of a single visit by the patient, in this visit the assembly and activation of the upper and lower orthodontic appliances will be carried out. Measurements of the primary outcome variable will be done remotely through a virtual pain monitoring questionnaire through a visual analog scale (Baseline, 12 hours, 24 hours, 48 hours, 72 hours). After Screening a computer-generated scrambling code will be used for allocation in blocks of 6 to the two treatments. The identity of included patients will not be provided to the trial team, in order to preserve the blinded aspect of the trial. The identity of the research treatment associated with each randomization number will be hidden from the trial team and patients. The final analysis is scheduled for when 100% of the patients (60 subjects) reach the 72-hour evaluation.

Official Title
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Low Level 810nm Laser Therapy on Controlling Pain During a First Stage of Orthondontic Treatment

Conditions
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Malocclusion

Intervention / Treatment
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* Device: Laser
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have signed and dated an informed consent form approved by the IRB in accordance with regulatory and institutional guidelines. This form must be obtained before performing any procedure related to the protocol that is not part of the subject's normal regimen. No need extractions No need Stripping Exclusion Criteria: Periodontal disease Pregnant or lactance Medicated patients (analgesic, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers) Cardiac markpaser

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Sixty patients (60) will be randomized in a 1: 1 ratio, to either of the two arms of this trial. Measurements of the primary outcome variable will be done remotely through a virtual pain monitoring questionnaire through a visual analog scale (Baseline, 12 hours, 24 hours, 48 hours, 72 hours)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>The low-power therapeutic diode laser will be applied with a wavelength 810nm ± 15nm, output power 0-2 W CW / 0-4.8 W peak power (pulse mode), for a time of 20 seconds per centimeter at lo along the buccal surface of the root of the upper and lower teeth. | Device: Laser<br>* The laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.<br>* Other names: LLLT;|
| Placebo Comparator: Placebo<br>A simulation of the application of therapeutic laser will be carried out as a placebo effect, for a time of 20 seconds per centimeter along the vestibular surface of the root of the upper and lower teeth. | Other: Placebo<br>* Simulation laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.<br>* Other names: Simulation laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the Change in Orthodontic Pain Levels | The evaluation of the difference in pain levels will be determined as a percentage of change and difference in means of pain levels. The difference and the percentage will be calculated by comparing the baseline pain levels observed between the different follow-up times. A rule of three is applied to determine the percentage of change (%) and a subtraction of the pain averages to calculate the difference. Pain analysis will be performed using the visual analog scale (VAS) | Baseline (before treatment), 12 hours (after the start of treatment), 24 hours (after the start of treatment) 48 hours (after the start of treatment) 72 hours(after the start of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for analgesic | Frequency and Need after the treatment | Baseline (before treatment), 12 hours (after the start of treatment), 24 hours (after the start of treatment) 48 hours (after the start of treatment) 72 hours(after the start of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser, orthodontic, TIP EDGE