Pain induced as an adverse effect of the elastic separator procedure, which is a preliminary treatme
Conditions
Interventions
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, ave
Sponsors
Tanimoto Kotaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resting pain one day after laser irradiation, evaluated using the Visual Analog Scale (VAS). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactRyo Kunimatsu
Graduate School of Biochemical and Health Sciences, Hiroshima University
Outcome results
None listed