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

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ClinicalTrials.gov Identifier: NCT03939988
Recruitment Status : Not yet recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Sandra Kalil Bussadori, University of Nove de Julho

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Orthodontic Appliance Complication Radiation: Photobiomodulation Radiation: Placebo photobiomodulation Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: In the Placebo group, participants will receive the simulated application with the laser set off, only using the beep to play the application. Therefore, they not know to which group they belong.
Primary Purpose: Treatment
Official Title: Evaluation of the Use of Photobiomodulation After the Installation of Elastometric Separators - Randomized Controlled Clinical Trial.
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 15, 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Experimental group
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
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.
Placebo Comparator: Placebo group
In the placebo group, the same procedures will be made, but the laser will be switched off.
 Radiation: Placebo photobiomodulation
In the placebo group, the same procedures will be made, but the laser will be turned off.


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analog Scale (pain measurement) [ Time Frame: Immediately after treatment. ]
    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.


Secondary Outcome Measures :
  1. Change in IL-8 cytokine [ Time Frame: Baseline and immediately after treatment. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sandra Kalil Bussadori, Principal Investigator, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT03939988    
Other Study ID Numbers: Silvana
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No