The Effect of Low-level Laser Therapy to Reduce Pain Caused by Orthodontic Separators: A Randomized, Double-blind Place-bo-controlled, Split-mouth Study
NCT ID: NCT06816537
Last Updated: 2025-02-13
Study Results
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Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2021-07-05
2021-12-23
Brief Summary
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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).
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Detailed Description
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Therefore, the aim of the present study will be to assess the effect of LLLT in reducing pain following orthodontic elastic separator placement in individuals treated with fixed orthodontic appliances, using a randomized, double-blind placebo-controlled split-mouth study design.
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
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Low level laser therapy
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
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
No intervention
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 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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* patients who had undergone prior oral LLLT
* who were using painkillers or other NSAIDs
* those who were consumed tobacco products
* pregnant or lactating women
18 Years
50 Years
ALL
Yes
Sponsors
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Szeged University
OTHER
Responsible Party
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Melinda Madléna
Full professor
Principal Investigators
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Melinda Madléna, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, University of Szeged
Locations
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Department of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, University of Szeged
Szeged, Csongrád-Csanád, Hungary
Countries
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References
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Walsh LJ. The current status of low level laser therapy in dentistry. Part 1. Soft tissue applications. Aust Dent J. 1997 Aug;42(4):247-54. doi: 10.1111/j.1834-7819.1997.tb00129.x.
Ren C, McGrath C, Yang Y. The effectiveness of low-level diode laser therapy on orthodontic pain management: a systematic review and meta-analysis. Lasers Med Sci. 2015 Sep;30(7):1881-93. doi: 10.1007/s10103-015-1743-4. Epub 2015 Mar 24.
Farzan A, Khaleghi K. The Effectiveness of Low-Level Laser Therapy in Pain Induced by Orthodontic Separator Placement: A Systematic Review. J Lasers Med Sci. 2021 Jun 24;12:e29. doi: 10.34172/jlms.2021.29. eCollection 2021.
Qamruddin I, Alam MK, Fida M, Khan AG. 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 Jan;149(1):62-6. doi: 10.1016/j.ajodo.2015.06.024.
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.
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.
Nobrega C, da Silva EM, de Macedo CR. 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 Jan;31(1):10-6. doi: 10.1089/pho.2012.3338. Epub 2012 Nov 15.
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.
Xiaoting L, Yin T, Yangxi C. Interventions for pain during fixed orthodontic appliance therapy. A systematic review. Angle Orthod. 2010 Sep;80(5):925-32. doi: 10.2319/010410-10.1.
Youssef M, Ashkar S, Hamade E, Gutknecht N, Lampert F, Mir M. The effect of low-level laser therapy during orthodontic movement: a preliminary study. Lasers Med Sci. 2008 Jan;23(1):27-33. doi: 10.1007/s10103-007-0449-7. Epub 2007 Mar 15.
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.
Turhani D, Scheriau M, Kapral D, Benesch T, Jonke E, Bantleon HP. Pain relief by single low-level laser irradiation in orthodontic patients undergoing fixed appliance therapy. Am J Orthod Dentofacial Orthop. 2006 Sep;130(3):371-7. doi: 10.1016/j.ajodo.2005.04.036.
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.
Harazaki M, Isshiki Y. Soft laser irradiation effects on pain reduction in orthodontic treatment. Bull Tokyo Dent Coll. 1997 Nov;38(4):291-5.
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.
Other Identifiers
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SZTE-DENT-2020-38078-6
Identifier Type: -
Identifier Source: org_study_id
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