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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

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

Clinicaltrials.gov identifier NCT03939988

Recruitment Status Not yet recruiting

First Posted May 7, 2019

Last update posted May 7, 2019

Study Description

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:Orthodontic Appliance Complication
  • Intervention/Treatment: Radiation: Photobiomodulation
    Radiation: Placebo photobiomodulation
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 72 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • 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 2019
  • Estimated Primary Completion Date: September 2019
  • Estimated Study Completion Date: December 2019
Arms and interventions
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
  • 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
  • Ages Eligible for Study: 12 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
Contacts
Locations
Sponsors and Collaborators

University of Nove de Julho

More Information
  • Responsible Party: University of Nove de Julho
  • ClinicalTrials.gov Identifier: NCT03939988 History of Changes
  • Other Study ID Numbers: Silvana
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 7, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No