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

University of Nove de Julho

Status and phase: Unknown; Phase 1

Conditions: Orthodontic Appliance Complication

Treatments: Radiation: Photobiomodulation; Radiation: Placebo photobiomodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03939988

Silvana

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 12 to 26 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups, including a placebo group

Experimental group

Active Comparator group

Description:

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.

Treatment:

Radiation: Photobiomodulation

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Radiation: Placebo photobiomodulation