Evaluation of the Use of Photobiomodulation After the Installation of Elastometric Separators

Study Overview
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Brief Summary
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The greatest dropout rate of orthodontic treatments is pain, from the installation of the elastomeric separators, to the exchange of wires and accessories. This process that presents both physiological and psychological responses negatively affects patients' quality of life due to the difficulty of chewing and biting. The sample will be comprised of individuals who will receive elastomeric spacers on the mesial and distal surfaces of the upper first molars, randomized into two groups, the group being irradiated with the low intensity laser, called the experimental group, and the placebo group, simulated laser. In the installation of the tabs, the experimental group will receive a single application in the mesial and distal cervical portion and in the apical third of the molars. The energy delivered at each point will be 2J, per vestibular and lingual, 6 points, totaling 12 J of energy per tooth. To evaluate the perception of pain we will use the Visual Analogue Scale (EVA) after 1h, for all groups. The gingival pockets cytokines will be collected with an absorbent paper cone for 30 seconds on both groups and compared between them by ELISA. It is expected that patients in the irradiated group will have lower pain perception and less cytokines than in the placebo group.

Official Title
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Evaluation of the Use of Photobiomodulation After the Installation of Elastometric Separators - Randomized Controlled Clinical Trial.

Conditions
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Orthodontic Appliance Complication

Intervention / Treatment
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* Radiation: Photobiomodulation
* Radiation: Placebo photobiomodulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical conditions of normality; Healthy periodontium; Healthy molars; Presence of interproximal contacts between the second molar and premolar; Permanent dentition phase; Who have not been taking anti-inflammatory drugs or analgesics for 4 days. Exclusion Criteria: Systemic diseases that routinely use medications; Patients with periodontal disease; Patients who remove the tabs or who do not respond to the questionnaire; Papers contaminated with blood or saliva will be excluded for cytokine analysis.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 26 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental group<br>In this study, immediately after the installation of the separators, the subjects of the experimental group will be submitted to photobiomodulation. The laser will be infrared, in continuous mode with wavelength of 808 nm. The tip will be positioned perpendicularly in the mucosa, without exerting pressure. At each point 2J of energy will be irradiated for 20 seconds, totaling 12J per tooth, 6J on the buccal side and 6J of the lingual side of the teeth. | Radiation: Photobiomodulation<br>* Immediately after the installation of the separators, the subjects will be submitted to photobiomodulation. The laser will be infrared, in continuous mode with wavelength of 808 nm. The tip will be positioned perpendicularly in the mucosa, without exerting pressure. At each point 2J of energy will be irradiated for 20 seconds, totaling 12J per tooth, 6J on the buccal side and 6J of the lingual side of the teeth.<br>|
| Placebo Comparator: Placebo group<br>In the placebo group, the same procedures will be made, but the laser will be switched off. | Radiation: Placebo photobiomodulation<br>* In the placebo group, the same procedures will be made, but the laser will be turned off.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (pain measurement) | After an hour of installation of the separators, patients will respond to pain perception, being instructed to quantify their level of discomfort by measuring the VAS. The scale was converted into 11 points, 0 to 10, where 0 refers to the absence of pain and 10 levels of intolerable pain. | Immediately after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IL-8 cytokine | We will insert absorbent tissue cones at the sampling sites (gingival pockets), before and one hour after the insertion of the separators. The levels of cytokines will be analyzed by the ELISA interleukin kits method, strictly following the manufacturer's instructions, by the same examiner. | Baseline and immediately after treatment. |