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

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

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.

Study Overview

• Status: Unknown
• Conditions: Orthodontic Appliance Complication
• Intervention / Treatment: Radiation: Photobiomodulation; Radiation: Placebo photobiomodulation

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Nove de Julho

Publications and helpful links

General Publications

• Ortega SM, Goncalves MLL, da Silva T, Horliana ACRT, Motta LJ, Altavista OM, Olivan SR, Santos AECGD, Martimbianco ALC, Mesquita-Ferrari RA, Fernandes KPS, Bussadori SK. Evaluation of the use of photobiomodulation following the placement of elastomeric separators: Protocol for a randomized controlled clinical trial. Medicine (Baltimore). 2019 Oct;98(43):e17325. doi: 10.1097/MD.0000000000017325.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): September 30, 2019
• Study Completion (Anticipated): December 15, 2019

Study Registration Dates

• First Submitted: May 4, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Silvana

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No