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Evaluation of the Efficacy and Safety of Diode Laser Irradiation for Pain Following Separator Placement in Orthodontic Treatment

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Pain induced as an adverse effect of the elastic separator procedure, which is a preliminary treatme
Date of first enrollment	27/01/2026
Target sample size	50
Countries of recruitment
Study type	Interventional
Intervention(s)	After performing the separation procedure on the maxillary bilateral first molars, diode laser X will be applied using the following parameters: wavelength 808 nm plus minus 20 nm, peak power 7 W, average power 0.7 W, frequency 5 Hz, pulse width 20 ms, duty cycle 10%, and hemostatic probe efficiency 80%. Laser irradiation will be administered for 14.6 seconds per point (energy density 16.25 J/cm2) at a total of six points corresponding to the mesial, distal, and middle areas of the gingiva over the palatal and buccal root regions between the maxillary unilateral first and second molars, resulting in a total irradiation time of 87.6 seconds (total energy density 97.5 J/cm2).On the contralateral side, a placebo irradiation will be performed in which no light energy is emitted and only the operating sound of the device is produced.

Outcome(s)

Primary Outcome

Resting pain one day after laser irradiation, evaluated using the Visual Analog Scale (VAS).

Secondary Outcome

Time-dependent changes in resting pain (VAS): Measurements will be taken 30 minutes, 1 hour, and 6 hours after laser irradiation, and once daily from Day 1 to Day 7. Time-dependent changes in pain during occlusion (VAS): Measurements will be taken 6 hours after laser irradiation, and once daily from Day 1 to Day 7. Detailed time-dependent changes in resting pain (Short-Form McGill Pain Questionnaire-2; SF-MPQ-2): Measurements will be taken 30 minutes, 1 hour, and 6 hours after laser irradiation, and once daily from Day 1 to Day 7. Changes in the surface temperature of the intraoral tissues: Measurements will be taken before irradiation, immediately after irradiation, and at 15 minutes, 30 minutes, and 1 hour after irradiation.

Key inclusion & exclusion criteria

Age minimum	>= 16age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients diagnosed with malocclusion who are scheduled to undergo comprehensive orthodontic treatment. Patients who are 16 years of age or older at the time written informed consent is obtained. Patients in the permanent dentition stage in whom eruption of the maxillary bilateral second premolars, first molars, and second molars has been completed. Patients who do not have any orthodontic appliances attached to the mandibular dentition. Patients who require placement of separators for the trial fitting and adjustment of bands on the maxillary bilateral first molars. Patients from whom written informed consent to participate in this study can be obtained. In the case of minors aged 16 years 0r older, written consent shall be obtained both from the participant and from a legally authorized representative.
Exclude criteria	Patients presenting with moderate or greater alveolar bone loss and/or periodontal pockets of 4 mm or deeper in the maxillary bilateral first molar region. Patients with dental caries classified as C3 or higher, pulpitis of C3 severity or higher, or previous endodontic treatment in the maxillary first molars, second molars, or second premolars. Patients with tumors, ulcers, mucosal diseases, labial herpes, or moderate or severe gingivitis in the oral or maxillofacial tissues. Patients with metabolic bone disorders, osteoporosis, or those currently receiving medication for diseases related to bone metabolism. Patients with an implanted pacemaker or implantable cardioverter-defibrillator (ICD). Patients who are pregnant. Patients taking anti-inflammatory analgesics or antibiotics within one week prior to laser irradiation, or patients currently taking immunosuppressive drugs such as corticosteroids. Patients with neuropathic pain, chronic pain, or acute pain. Patients who are unable to express their free will. Patients who are deemed unsuitable for participation in this study by the principal investigator or a co-investigator.