Orthodontic PainSZTEDENT-laserNCT06816537
The Effect of Low-level Laser Therapy to Reduce Pain Caused by Orthodontic Separators: A Randomized, Double-blind Place-bo-controlled, Split-mouth Study
A study testing Low Level Laser Therapy in people with Orthodontic Pain, run by Szeged University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Pain
- What is being tested?
- Low Level Laser Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteHungary
- Study dates
- 5 Jul 2021to 23 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- those who did not fulfill the general inclusion criteria
- patients who had undergone prior oral LLLT
- who were using painkillers or other NSAIDs
- those who were consumed tobacco products
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Department of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, University of Szeged
Szeged, Csongrád-Csanád, 6720
About this study
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.
Read more
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).
Read the detailed description
After finishing the development of the jaws, effective treatment of orthodontic anomalies needs fixed appliances. During initiation of routine orthodontic treatment with fixed appliances, placing elastic separators is a part of the process to achieve adequate space for orthodontic bands, which may lead to a considerable pain experience. This pain experience is a key barrier to the completion of orthodontic treatment processes, therefore, different approaches have been considered to reduce pain due to orthodontic treatment. Earlier studies have evaluated the effects of low level laser therapy (LLLT) on reducing pain caused by orthodontic elastic separators, however, the reported results are still contradictory: while some investigations supported the notion of analgetic effects, while other studies could not verify it. Therefore, due to the controversial position of LLLT as a treatment modality in orthodontic pain, recent reviews on this topic indicated that further, well-designed randomized controlled trials are needed to clarify the role and usefulness of LLLT in reduction of orthodontic pain.
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
- Orthodontic Pain
- Being tested
- Low Level Laser Therapy, No Interventions
- Keywords
- orthodontics, orthodontic pain, low-level laser therapy, LLLT, laser, oral health, mandible
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyRadiation
A low-level medical gallium-aluminum-arsenide (GaAlAs) diode laser device will be used on the 1st permanent molars in the test quadrants
No InterventionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start5 Jul 2021
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Orthodontic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- randomized, double-blind placebo-controlled (RDBPC) split-mouth study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melinda Madléna, Szeged University
- Investigators
- Melinda Madléna, Prof. Dr., Principal investigator, Department of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, University of Szeged
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816537
- Sponsor's protocol ID
- SZTE-DENT-2020-38078-6
- Acronym
- SZTEDENT-laser
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9316312Ren 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.
PubMed 25800534Farzan 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.
PubMed 34733752Qamruddin 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.
PubMed 26718379Farias 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.
PubMed 26132512Eslamian 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.
PubMed 23334785Nobrega 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.
PubMed 23153291Artes-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.
PubMed 22814893Xiaoting 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.
PubMed 20578865Youssef 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.
PubMed 17361391Tortamano 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.
PubMed 19892282Turhani 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.
PubMed 16979496Lim 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.
PubMed 7503039Harazaki M, Isshiki Y. Soft laser irradiation effects on pain reduction in orthodontic treatment. Bull Tokyo Dent Coll. 1997 Nov;38(4):291-5.
PubMed 9566142Dezfully 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.
PubMed 40422601
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-level Laser Therapy to Reduce Pain Caused by Orthodontic Separators: A Randomized, Double-blind Place-bo-controlled, Split-mouth Study
- ClinicalTrials.gov ID
- NCT06816537
- Acronym / sponsor ID
- SZTEDENT-laser / SZTE-DENT-2020-38078-6
- Conditions
- Orthodontic Pain
- Keywords
- orthodontics, orthodontic pain, low-level laser therapy, LLLT, laser, oral health, mandible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
After finishing the development of the jaws, effective treatment of orthodontic anomalies needs fixed appliances. During initiation of routine orthodontic treatment with fixed appliances, placing elastic separators is a part of the process to achieve adequate space for orthodontic bands, which may lead to a considerable pain experience. This pain experience is a key barrier to the completion of orthodontic treatment processes, therefore, different approaches have been considered to reduce pain due to orthodontic treatment. Earlier studies have evaluated the effects of low level laser therapy (LLLT) on reducing pain caused by orthodontic elastic separators, however, the reported results are still contradictory: while some investigations supported the notion of analgetic effects, while other studies could not verify it. Therefore, due to the controversial position of LLLT as a treatment modality in orthodontic pain, recent reviews on this topic indicated that further, well-designed randomized controlled trials are needed to clarify the role and usefulness of LLLT in reduction of orthodontic pain.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- randomized, double-blind placebo-controlled (RDBPC) split-mouth study
| Arm | Type | Receives |
|---|---|---|
| Low level laser therapy | Experimental | Radiation: Low Level Laser TherapyA 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 |
| No intervention | Placebo comparator | Other: No InterventionsThe handpiece was also held on the placebo treatment side without laser irradiation (fake irradiation) following the same application protocol as the LLLT treatment side. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- those who did not fulfill the general inclusion criteria
- patients who had undergone prior oral LLLT
- who were using painkillers or other NSAIDs
- those who were consumed tobacco products
- pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Level Laser TherapyA low-level medical gallium-aluminum-arsenide (GaAlAs) diode laser device will be used on the 1st permanent molars in the test quadrants | Radiation | Low level laser therapy |
| No InterventionsThe 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 intervention |
Primary outcome
Changes in the level of pain
Time frame: 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)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Background: PubMed 9316312Walsh 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.
- Background: PubMed 25800534Ren 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.
- Background: PubMed 34733752Farzan 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.
- Background: PubMed 26718379Qamruddin 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.
- Background: PubMed 26132512Farias 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.
- Background: PubMed 23334785Eslamian 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.
- Background: PubMed 23153291Nobrega 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.
- Background: PubMed 22814893Artes-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.
- Background: PubMed 20578865Xiaoting 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.
- Background: PubMed 17361391Youssef 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.
- Background: PubMed 19892282Tortamano 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.
- Background: PubMed 16979496Turhani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melinda Madléna, Prof. Dr. principal investigator
Department of Orthodontics and Pediatric Dentistry, Faculty of Dentistry, University of Szeged
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy in people with Orthodontic Pain, run by Szeged University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the level of pain (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06816537, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.