Clinical trial NCT03939988: Evaluation of the Use of Photobiomodulation After the Installation of Elastometric Separators
Official title: Evaluation of the Use of Photobiomodulation After the Installation of Elastometric Separators - Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Orthodontic Appliance Complication
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 72
Sex: ALL
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Visual Analog Scale (pain measurement)
timeFrame: Immediately after treatment.
Secondary outcomes:
measure: Change in IL-8 cytokine
timeFrame: Baseline and immediately after treatment.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.