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

NCT06816537 | Completed

• 1 other identifier: SZTE-DENT-2020-38078-6
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Orthodontic Pain

Keywords

orthodontics; orthodontic pain; low-level laser therapy; LLLT; laser; oral health; mandible

Outcome Measures

Primary Outcomes (1)

• Changes in the level of pain

  Patients were instructed to denote their pain sensation levels according to the localization (upper/lower jaw; right/left side) after treatment (laser/placebo) in resting position of the mandible (spontaneous pain) and during mastication, on a Visual Analog Scale (VAS), from 0 (no pain) to 100 (severe pain).

  At 0 hours (h) (i.e. within 5 minutes of placing the elastic separators), at 6 hours (h) (±30 minutes), at 12 hours (±30 minutes), at 24 hours (±30 minutes), at 48 hours (±30 minutes) and at 72 hours (±30 minutes) after treatment (laser/placebo)

Study Arms (2)

Low level laser therapy

EXPERIMENTAL

A low-level medical gallium-aluminum-arsenide (GaAlAs) diode laser device will used on the 1st permanent molars in the test quadrants, to decrease pain associated with the placement of orthodontic separators

Radiation: Low Level Laser Therapy

No intervention

PLACEBO COMPARATOR

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.

Other: No Interventions

Interventions

Low Level Laser Therapy RADIATION

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

Low level laser therapy

No Interventions OTHER

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.

No intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• individuals aged between 18 and 50 years
• completely erupted second molars without open interproximal contacts of the first molars
• good general health, without the existence of systemic diseases
• adequate oral hygiene and healthy periodontium
• no previous orthodontic treatment

You may not qualify if:

• patients who had undergone prior oral LLLT
• who were using painkillers or other NSAIDs
• those who were consumed tobacco products
• pregnant or lactating women

Sponsors & Collaborators

• Szeged University: lead

Study Sites (1)

Department of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, University of Szeged

Szeged, Csongrád-Csanád, 6720, Hungary

Location

Related Publications (15)

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  PMID: 26718379 BACKGROUND

• Farias RD, Closs LQ, Miguens SA Jr. Evaluation of the use of low-level laser therapy in pain control in orthodontic patients: A randomized split-mouth clinical trial. Angle Orthod. 2016 Mar;86(2):193-8. doi: 10.2319/122214-933.1. Epub 2015 Jul 1.

  PMID: 26132512 BACKGROUND

• Eslamian L, Borzabadi-Farahani A, Hassanzadeh-Azhiri A, Badiee MR, Fekrazad R. The effect of 810-nm low-level laser therapy on pain caused by orthodontic elastomeric separators. Lasers Med Sci. 2014 Mar;29(2):559-64. doi: 10.1007/s10103-012-1258-1. Epub 2013 Jan 20.

  PMID: 23334785 BACKGROUND

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• Artes-Ribas M, Arnabat-Dominguez J, Puigdollers A. Analgesic effect of a low-level laser therapy (830 nm) in early orthodontic treatment. Lasers Med Sci. 2013 Jan;28(1):335-41. doi: 10.1007/s10103-012-1135-y. Epub 2012 Jul 21.

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  PMID: 17361391 BACKGROUND

• Tortamano A, Lenzi DC, Haddad AC, Bottino MC, Dominguez GC, Vigorito JW. Low-level laser therapy for pain caused by placement of the first orthodontic archwire: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2009 Nov;136(5):662-7. doi: 10.1016/j.ajodo.2008.06.028.

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• Lim HM, Lew KK, Tay DK. A clinical investigation of the efficacy of low level laser therapy in reducing orthodontic postadjustment pain. Am J Orthod Dentofacial Orthop. 1995 Dec;108(6):614-22. doi: 10.1016/s0889-5406(95)70007-2.

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  PMID: 9566142 BACKGROUND

• Dezfully AK, Gajdacs M, Pato AE, Karpati K, Madlena M. The Effect of Low-Level Laser Therapy to Reduce Pain Caused by Orthodontic Separators: A Randomized, Double-Blind Placebo-Controlled, Split-Mouth Study. Dent J (Basel). 2025 Apr 22;13(5):181. doi: 10.3390/dj13050181.

  PMID: 40422601 DERIVED

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Melinda Madléna, Prof. Dr.

  Department of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, University of Szeged

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Model Details: randomized, double-blind placebo-controlled (RDBPC) split-mouth study

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: July 5, 2021
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2021
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)