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

NCT07456709 | Completed

• 1 other identifier: SZTE-DENT-2021-38078-6
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes in the level of pain

  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, on a Visual Analog Scale (VAS), ranging 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 (4)

Low level laser therapy (6J, continuous)

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

Low level laser therapy (6J, pulse)

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

Low level laser therapy (12 J, continuous)

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 (12 J, continuous); Low level laser therapy (6J, continuous); Low level laser therapy (6J, pulse)

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 overall health, without the existence of known systemic disorders
• being caries-free without gingivitis or any other periodontal problems
• no previous orthodontic treatment in the medical history
• willing to participate in the study

You may not qualify if:

• prior oral LLLT treatment in the medical history
• use of NSAIDs, other analgesic drugs or local anesthetics for pain management 6 weeks before the initiation of orthodontic treatment
• consumption of any type of 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 (10)

• Golshah, A.; Kazemisaleh, A.; Azizi, F.; Nejad, A.H. Effect of single-dose diode laser photobiomodulation on orthodontic pain following initial archwire placement: a randomized clinical trial BMC Oral Health 2025, 25, e973.

  BACKGROUND

• Dezfully, A.K.; Gajdács, M.; Pató, A.E.; Kárpáti, K.; Madléna, 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. 2025, 13,181-196.

  BACKGROUND

• Furquim, R.D.; Pascotto, R.C.; Rino Neto, J.; Cardoso, J.R.; Ramos, A.L. Low-level laser therapy effects on pain perception related to the use of orthodontic elastomeric separators. Dental Press J. Orthod. 2015, 20, 37-42.

  BACKGROUND

• Gupta, S.; Ahuja, S.; Bhambri, E.; Sharma, S.; Sharma, R.; Kalia, H. Evaluating the effect of low-level laser therapy on pain induced by orthodontic separation: a randomized split-mouth clinical trial. Lasers Dent. Sci. 2018, 2, 221-228.

  BACKGROUND

• Qamruddin, I.; Alam, M.K.; Fida, M.; Khan, A.G. Effect of a single dose of low-level laser therapy on spontaneous and chewing pain caused by elastomeric separators. Am. J. Orthod. Dentofacial Orthop. 2016, 149, 62-66.

  BACKGROUND

• Nóbrega, C.; da Silva, E.M.; de Macedo, C.R. Low-level laser therapy for treatment of pain associated with orthodontic elastomeric separator placement: a placebo-controlled randomized double-blind clinical trial. Photomed. Laser Surg. 2013, 31, 10-16.

  BACKGROUND

• Inchingolo, F.; Inchingolo, A.M.; Latini, G.; Del Vecchio, G.; Trilli, I.; Ferrante, L.; Dipalma, G.; Palermo, A..; Inchingolo, A.D. Low-Level Light Therapy in Orthodontic Treatment: A Systematic Review. Appl. Sci. 2023, 13, e10393.

  BACKGROUND

• Harazaki M.; Isshiki Y. Soft laser irradiation effects on pain reduction in orthodontic treatment. Bull. Tokyo Dent. Coll. 1997, 38, 291 295.

  BACKGROUND

• Wang, J.; Jian, F.; Chen, J.; Ye, N.S.; Huang, Y.H.; Wang, S.; Huang, R.H.; Pei, J.; Liu, P.; Zhang, L.; Zhao, Z.H.; Chen, Q.M.; Lai, W.L.; Lin, Y.F.. Cognitive behavioral therapy for orthodontic pain control: A randomized trial. J. Dent. Res. 2012, 91, 580-585.

  BACKGROUND

• Xiaoting, L.; Yin, T.; Yangxi, C. Interventions for pain during fixed orthodontic appliance therapy: A systematic review. Angle Orthodont. 2010, 80, 925-932.

  BACKGROUND

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: PARALLEL
• 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: March 2, 2026
• First Posted: March 6, 2026
• Study Start: November 26, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)