Efficacy of Different Regiments of 980 nm Low-Level Laser Therapy to Reduce Pain Caused by Orthodontic Separators: A Randomized, Double-Blind, Split-Mouth Placebo-Controlled Study

Summary

Thirty-one (n=31) participants from the Department of Orthodontics and Pediatric Dentistry, University of Szeged will be randomly assigned using a split-mouth design, to avoid inter-individual variability between participants from confounding our results.

Patients' upper and lower dental arches will be divided into right and left halves (i.e. quadrants). In each participant, three quadrants will be used to administer the different LLLT treatment regimens, while the fourth quadrant will be designated for placebo. The random assignment of quadrants to receive LLLT or placebo will be determined using cards denoting the possible four quadrants and the four treatment variations, respectively. Participants will be asked to blindly choose from among the prepared cards to determine assignment; to ensure adherence to double-blinding, patients and the operator will be blinded to the assignment of quadrants and treatments.

In the treatment quadrants a low-level medical gallium-aluminum-arsenide (GaAlAs) diode laser device (wavelength 980 nm, power: 0.1-0.2W, producing 6-12 J energy), with either a continuous or pulsed wave mode will be used on the first permanent molars in the appropriate treatment (R1-R3) quadrants. The efficacy of the treatment will be evaluated in two energy-levels (i.e. intensity; 6 and 12 J, respectively) and regimes (continuous vs. pulsed). The assigned LLLT treatments in the appropriate three quadrants will be applied as follows: regiment 1 (R1: 6 J, continuous), regiment 2 (R2: 12 J, continuous), regiment 3 (R3: 6 J, pulsed), while placebo treatment (P) will be applied in the remaining, fourth quadrant. Using the split mouth design, patients will receive only a single dose immediately after the placement of orthodontic separators. Specified points in each quadrant will be treated from mesial, central and distal directions on the mucosa both buccally and lingually/palatinally with 10-10 sec for each, altogether for 60 sec, producing either 36 or 72 J of energy per molar. During the placebo treatment session, a similar procedure to that of the laser treatment session will be carried out, but with no laser irradiation. Therefore, to control the patient's pain-related behavior, and to maintain the blinded protocol, the handpiece will also be held on the placebo treatment side without laser irradiation following a similar application protocol.

Patients will be instructed to denote their pain sensation levels (which is expected to be the primary come measure of the study), using a self-administered, standardized questionnaire at the given appointments following the treatments: at 0 hours (i.e. within 5 minutes of placing the elastic separators), at 6 hours , at 12 hrs , at 24 hrs , at 48 hrs and at 72 hrs ,after treatment (R1-R2-R3-placebo) in resting position of the mandible (spontaneous pain) and during mastication, on a Visual Analog Scale (VAS), ranging from 0 (no pain) to 100 (severe pain).

Conditions

• Orthodontic Pain (D013850)

Interventions

RADIATION

Low Level Laser Therapy

A low-level medical gallium-aluminum-arsenide (GaAlAs) diode laser device will be used on the 1st permanent molars in the test quadrants

OTHER

No interventions

The handpiece was also held on the placebo treatment side without laser irradiation (fake irradiation) following the same application protocol as the LLLT treatment side.

Sponsors & Collaborators

• Szeged University

  lead OTHER

Principal Investigators

• Melinda Madléna, Prof. Dr. · Department of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, University of Szeged

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-26

Primary Completion

2022-03-31

Completion

2022-03-31

Countries

• Hungary

Study Locations