Orthodontic Pain (D013850)SZTEDENTlaser2NCT07456709
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
A study testing Low Level Laser Therapy in people with Orthodontic Pain (D013850), run by Szeged University at 1 site in Hungary.
Trial 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. 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 (D013850)
- 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
- 31 participants
- Where
- 1 siteHungary
- Study dates
- 26 Nov 2021to 31 Mar 2022
- 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 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
Who cannot join
- those who did not fulfill the general inclusion criteria or unwilling to take part in the study
- 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
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-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.
Read more
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).
Read the detailed description
Effective reduction of pain is crucial during a variety of dental treatments - in-cluding orthodontic therapy, especially during treatments with fixed appliances - to ensure adequate compliance of patients. Existing evidence has highlighted that over 9 out of 10 patients reported experiencing substantial pain during orthodontic treatment, with as much as 30% opting to discontinue therapy. In practice, before the initiation of effective orthodontic interventions, orthodontists place elastomeric separators (ES) to make enough room for the subsequent use of orthodontic bands. This intervention may result in a considerable pain experience for the patients. In recent years, Low Level Laser Therapy (LLLT), a non-surgical, minimally invasive method, has received substantial attention in a variety of dental domains, including tooth movement, tissue regeneration and healing, implant stability, and increasingly, as an effective analgesic treatment modality. LLLT, as defined by devices operating with an output below 0.5 W, have a low energy output to preclude an increase in temperature above normal body temperature in target tissues. If used carefully, under the supervision of an experienced operator, LLLTs has substantial advantages over conventional analgesic modalities (e.g., pharmaceuticals, such as non-steroidal anti-inflammatory drugs (NSAIDs)), as they do not present with the adverse systemic effects (e.g., altering bone resorption processes, xerostomia) associated with their use.
In our previous study, the researchers assessed the efficacy of LLLT - in the form of a 980 nm wavelength, 0.1 W energy diode laser - as a modality for pain reduction following orthodontic separation in individuals treated with fixed ortodontic appliances, within the framework of a double-blind, placebo controlled split-mouth study design. Our findings demonstrated that continuously applied LLLT with 6 J energy may have beneficial effects on orthodontic pain caused by ES, especially after 6 hrs of ES placement. However, as there is a dearth of evidence pertaining to the specifics on the most effective utilization of LLLT for or-thodontic pain reduction (e.g., energy, application mode, time), the present clinical study aims to evaluate the effect of LLLT vs. placebo, following orthodontic ES placement in patients treated with fixed orthodontic appliances, introducing variables not assessed in our earlier placebo controlled study.
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)
- Being tested
- Low Level Laser Therapy, No interventions
- Keywords
- orthodontics, orthodontic pain, low-level laser therapy, LLLT, laser, oral health, jawbone
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 (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 Receives: 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 Receives: 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 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 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).
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 posted6 Mar 2026
- Study start26 Nov 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Pain (D013850)Studies 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
- Parallel groups
- Model description
- randomized, double-blind placebo-controlled (RDBPC) split-mouth study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 31 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
- NCT07456709
- Sponsor's protocol ID
- SZTE-DENT-2021-38078-6
- Acronym
- SZTEDENTlaser2
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Golshah A, Kazemisaleh A, Azizi F, Nejad AH. Effect of single-dose diode laser photobiomodulation on orthodontic pain following initial archwire placement: a randomized clinical trial. BMC Oral Health. 2025 Jul 1;25(1):973. doi: 10.1186/s12903-025-06326-2.
PubMed 40597118Dezfully 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 40422601Furquim RD, Pascotto RC, Rino Neto J, Cardoso JR, Ramos AL. Low-level laser therapy effects on pain perception related to the use of orthodontic elastomeric separators. Dental Press J Orthod. 2015 May-Jun;20(3):37-42. doi: 10.1590/2176-9451.20.3.037-042.oar.
PubMed 26154454Gupta, 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.
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.
PubMed 26718379Nobrega 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 23153291Inchingolo F, Inchingolo AM, Latini G, Ferrante L, Trilli I, Del Vecchio G, Palmieri G, Malcangi G, Inchingolo AD, Dipalma G. Oxidative Stress and Natural Products in Orthodontic Treatment: A Systematic Review. Nutrients. 2023 Dec 28;16(1):113. doi: 10.3390/nu16010113.
PubMed 38201943Harazaki M, Isshiki Y. Soft laser irradiation effects on pain reduction in orthodontic treatment. Bull Tokyo Dent Coll. 1997 Nov;38(4):291-5.
PubMed 9566142Wang J, Jian F, Chen J, Ye NS, Huang YH, Wang S, Huang RH, Pei J, Liu P, Zhang L, Zhao ZH, Chen QM, Lai WL, Lin YF. Cognitive behavioral therapy for orthodontic pain control: a randomized trial. J Dent Res. 2012 Jun;91(6):580-5. doi: 10.1177/0022034512444446. Epub 2012 Apr 4.
PubMed 22492277Xiaoting 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 20578865Dezfully AK, Gajdacs M, Pato AE, Karpati K, Madlena M. Efficacy of Different Regimens of 980 nm Low-Level Laser Therapy to Reduce Pain Caused by Elastomeric Separator Placement in Adults: A Randomized, Double-Blind, Split-Mouth Placebo-Controlled Study. J Clin Med. 2026 May 12;15(10):3731. doi: 10.3390/jcm15103731.
PubMed 42194693
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07456709
- Acronym / sponsor ID
- SZTEDENTlaser2 / SZTE-DENT-2021-38078-6
- Conditions
- Orthodontic Pain (D013850)
- Keywords
- orthodontics, orthodontic pain, low-level laser therapy, LLLT, laser, oral health, jawbone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 6 Mar 2026 (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-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).
Detailed description
Effective reduction of pain is crucial during a variety of dental treatments - in-cluding orthodontic therapy, especially during treatments with fixed appliances - to ensure adequate compliance of patients. Existing evidence has highlighted that over 9 out of 10 patients reported experiencing substantial pain during orthodontic treatment, with as much as 30% opting to discontinue therapy. In practice, before the initiation of effective orthodontic interventions, orthodontists place elastomeric separators (ES) to make enough room for the subsequent use of orthodontic bands. This intervention may result in a considerable pain experience for the patients. In recent years, Low Level Laser Therapy (LLLT), a non-surgical, minimally invasive method, has received substantial attention in a variety of dental domains, including tooth movement, tissue regeneration and healing, implant stability, and increasingly, as an effective analgesic treatment modality. LLLT, as defined by devices operating with an output below 0.5 W, have a low energy output to preclude an increase in temperature above normal body temperature in target tissues. If used carefully, under the supervision of an experienced operator, LLLTs has substantial advantages over conventional analgesic modalities (e.g., pharmaceuticals, such as non-steroidal anti-inflammatory drugs (NSAIDs)), as they do not present with the adverse systemic effects (e.g., altering bone resorption processes, xerostomia) associated with their use.
In our previous study, the researchers assessed the efficacy of LLLT - in the form of a 980 nm wavelength, 0.1 W energy diode laser - as a modality for pain reduction following orthodontic separation in individuals treated with fixed ortodontic appliances, within the framework of a double-blind, placebo controlled split-mouth study design. Our findings demonstrated that continuously applied LLLT with 6 J energy may have beneficial effects on orthodontic pain caused by ES, especially after 6 hrs of ES placement. However, as there is a dearth of evidence pertaining to the specifics on the most effective utilization of LLLT for or-thodontic pain reduction (e.g., energy, application mode, time), the present clinical study aims to evaluate the effect of LLLT vs. placebo, following orthodontic ES placement in patients treated with fixed orthodontic appliances, introducing variables not assessed in our earlier placebo controlled study.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- randomized, double-blind placebo-controlled (RDBPC) split-mouth study
| Arm | Type | Receives |
|---|---|---|
| Low level laser therapy (6J, continuous) | 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 |
| Low level laser therapy (6J, pulse) | 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 |
| Low level laser therapy (12 J, continuous) | 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 (6 listed)
- 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
Key exclusion criteria (5 listed)
- those who did not fulfill the general inclusion criteria or unwilling to take part in the study
- 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
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 (12 J, continuous), Low level laser therapy (6J, continuous), Low level laser therapy (6J, pulse) |
| 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 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).
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 11 Mar 2026.
- Background: PubMed 40597118Golshah A, Kazemisaleh A, Azizi F, Nejad AH. Effect of single-dose diode laser photobiomodulation on orthodontic pain following initial archwire placement: a randomized clinical trial. BMC Oral Health. 2025 Jul 1;25(1):973. doi: 10.1186/s12903-025-06326-2.
- Background: PubMed 40422601Dezfully 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.
- Background: PubMed 26154454Furquim RD, Pascotto RC, Rino Neto J, Cardoso JR, Ramos AL. Low-level laser therapy effects on pain perception related to the use of orthodontic elastomeric separators. Dental Press J Orthod. 2015 May-Jun;20(3):37-42. doi: 10.1590/2176-9451.20.3.037-042.oar.
- BackgroundGupta, 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: 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 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 38201943Inchingolo F, Inchingolo AM, Latini G, Ferrante L, Trilli I, Del Vecchio G, Palmieri G, Malcangi G, Inchingolo AD, Dipalma G. Oxidative Stress and Natural Products in Orthodontic Treatment: A Systematic Review. Nutrients. 2023 Dec 28;16(1):113. doi: 10.3390/nu16010113.
- Background: PubMed 9566142Harazaki M, Isshiki Y. Soft laser irradiation effects on pain reduction in orthodontic treatment. Bull Tokyo Dent Coll. 1997 Nov;38(4):291-5.
- Background: PubMed 22492277Wang J, Jian F, Chen J, Ye NS, Huang YH, Wang S, Huang RH, Pei J, Liu P, Zhang L, Zhao ZH, Chen QM, Lai WL, Lin YF. Cognitive behavioral therapy for orthodontic pain control: a randomized trial. J Dent Res. 2012 Jun;91(6):580-5. doi: 10.1177/0022034512444446. Epub 2012 Apr 4.
- 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.
- Derived from this study: PubMed 42194693Dezfully AK, Gajdacs M, Pato AE, Karpati K, Madlena M. Efficacy of Different Regimens of 980 nm Low-Level Laser Therapy to Reduce Pain Caused by Elastomeric Separator Placement in Adults: A Randomized, Double-Blind, Split-Mouth Placebo-Controlled Study. J Clin Med. 2026 May 12;15(10):3731. doi: 10.3390/jcm15103731.
- 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 (D013850), 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 6 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 11 Mar 2026. 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 NCT07456709, which also lists 11 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 11 Mar 2026.