NCT06816537: SZTEDENT-laser

The Effect of Low-level Laser Therapy to Reduce Pain Caused by Orthodontic Separators: A Randomized, Double-blind Place-bo-controlled, Split-mouth Study

Completed NA Last updated 13 February 2025

What this trial tests

NA trial testing Low Level Laser Therapy in Orthodontic Pain in 33 participants. Completed in 23 December 2021.

Timeline

5 July 2021

Primary endpoint
23 December 2021

23 December 2021

Quick facts

Lead sponsor	Szeged University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	supportive care
Enrollment	33
Start date	5 July 2021
Primary completion	23 December 2021
Estimated completion	23 December 2021
Sites	1 location across Hungary

Drugs / interventions tested

• Low Level Laser Therapy — full drug profile →
• No Interventions — full drug profile →

Conditions studied

• Orthodontic Pain — all drugs for Orthodontic Pain →

Sponsor

Szeged University

Who can join

Adults 18 to 50, any sex, with Orthodontic Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Thirty-three (n=33) participants from the Department of Orthodontics and Pediatric Dentistry, University of Szeged will be randomly assigned into two groups.

A randomly assigned, split-mouth design will be used to avoid inter-individual biologic variation between patients. First, it will be randomly determined whether the upper or lower jaw would be involved in the study; after choosing the jaw blindly, the actual dental arch in the mouth will further be divided vertically, into right and left halves (quadrants) in each patient. One half will be the experimental side (i.e. the test quadrant) and will receive laser therapy, while the other half will be the placebo side (i.e. placebo quadrant) which will receive no laser, only placebo therapy.

In the experimental group, a low-level medical gallium-aluminum-arsenide (GaAlAs) diode laser device (wavelength 980 nm, power: 100mW, producing 6 J energy), with continuous wave will used on the 1st permanent molars in the test quadrants. 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 36 J 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), according to the localization (upper/lower jaw; right/left side) and 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 (laser/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).

Publications & conference data

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

1. The Effect of Low-Level Laser Therapy to Reduce Pain Caused by Orthodontic Separators: A Randomized, Double-Blind Placebo-Controlled, Split-Mouth Study.
   Dezfully AK, Gajdács M, Pató AE, Kárpáti K, et al · · 2025 · PMID 40422601 · DOI 10.3390/dj13050181