Evaluation of the Use of Photobiomodulation After the Installation of Elastometric Separators
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03939988|
Recruitment Status : Not yet recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
University of Nove de Julho
Information provided by (Responsible Party):
Sandra Kalil Bussadori, University of Nove de Julho
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|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|
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.
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.
Primary Outcome Measures :
- 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 :
- 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.
No Contacts or Locations Provided