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

NCT ID: NCT03939988

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2019-12-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Photobiomodulation

Intervention Type: 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.

Placebo group

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

Group Type: PLACEBO_COMPARATOR

Placebo photobiomodulation

Intervention Type: RADIATION

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

Interventions

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.

Intervention Type: RADIATION

Placebo photobiomodulation

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

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 31651838 (View on PubMed)

Other Identifiers

Silvana

Identifier Type: -

Identifier Source: org_study_id