NCT03939988

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

Status unknown Phase 1 Last updated 7 May 2019

What this trial tests

Phase 1 trial testing Photobiomodulation in Orthodontic Appliance Complication in 72 participants. Status unknown.

Timeline

1 June 2019

Primary endpoint
30 September 2019

15 December 2019

Quick facts

Lead sponsor	University of Nove de Julho
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	72
Start date	1 June 2019
Primary completion	30 September 2019
Estimated completion	15 December 2019

Drugs / interventions tested

• Photobiomodulation
• Placebo photobiomodulation

Conditions studied

• Orthodontic Appliance Complication — all drugs for Orthodontic Appliance Complication →

Sponsor

University of Nove de Julho

Who can join

Adults 12 to 26, any sex, with Orthodontic Appliance Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluation of the use of photobiomodulation following the placement of elastomeric separators: Protocol for a randomized controlled clinical trial.
   Ortega SM, Gonçalves MLL, da Silva T, Horliana ACRT, et al · · 2019 · cited 5× · PMID 31651838 · DOI 10.1097/md.0000000000017325