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

NCT03939988 | Unknown Phase 1

• 1 other identifier: Silvana
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in IL-8 cytokine

  Baseline and immediately after treatment.

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

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

Placebo group

PLACEBO COMPARATOR

In the placebo group, the same procedures will be made, but the laser will be switched off.

Radiation: Placebo photobiomodulation

Interventions

Photobiomodulation RADIATION

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.

Experimental group

Placebo photobiomodulation RADIATION

In the placebo group, the same procedures will be made, but the laser will be turned off.

Placebo group

Eligibility Criteria

• Age: 12 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Related Publications (1)

• 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.

  PMID: 31651838 DERIVED

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2019
• First Posted: May 7, 2019
• Study Start: June 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 15, 2019
• Last Updated: May 7, 2019

Record last verified: 2019-05