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IRCT20250605066076N1 IRCT 2025-06-10 Kermanshah University of Medical Sciences Effect of Photobiomodulation on Pain Reduction After Miniscrew Placement in Orthodontics Investigating the Effectiveness of Photobiomodulation Therapy on Pain Reduction After Miniscrew Placement in Orthodontic Patients: A Randomized Clinical Trial 2025-06-22 anticipated 18 Complete https://irct.ir/trial/84120 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: This study employs a split-mouth design, where each participant simultaneously receives both the intervention (active photobiomodulation) and placebo (inactive laser) on different sides of the mouth. This design minimizes inter-individual variability and enhances the precision of the results by allowing each participant to serve as their own control, Randomization description: Randomization is performed using two series of random numbers in blocks of 2, 4, and 6, generated via www.sealedenvelope.com. The first series determines the side of the mouth for intervention, and the second series determines the type of intervention (active laser or placebo). Allocation concealment is ensured using sealed opaque envelopes, each containing codes A or B. Randomization is conducted by an independent researcher not involved in treatment or assessment. Patient enrollment is performed by an orthodontist, and intervention allocation is conducted by a trained assistant, Blinding description: This study is designed as a double-blind trial. Participants are unaware of the intervention allocation (active laser or placebo) on each side of the mouth, as the laser device used for both active and placebo interventions has identical appearance, sound, and application procedure. Outcome assessors, responsible for evaluating pain using the Visual Analog Scale (VAS) and assessing the gingival index, are blinded to the intervention allocation, as data collection forms and clinical examinations do not indicate which side received the active or placebo treatment. Blinding is maintained through standardized laser application protocols and sealed randomization codes managed by an independent researcher. The clinical caregiver (orthodontist administering the intervention) and the data analyst are not blinded due to the requirements of intervention delivery and data analysis. N/A Pain following miniscrew placement in orthodontic treatment. Intervention 1: Intervention group: Photobiomodulation therapy using a diode laser with a wavelength of 940 nanometers, power of 300 milliwatts, and energy density of 31.7 joules per square centimeter in continuous wave mode, applied for 180 seconds to the tissue surrounding the miniscrew on one side of the mouth. The laser is administered with a spot size of 1.7 square centimeters, moving from the surrounding tissue toward the center, by a trained operator. Intervention 2: Control group: Placebo with an inactive laser applied for 180 seconds to the tissue surrounding the miniscrew on the opposite side of the mouth. The procedure mimics the active laser application in appearance, sound, and duration to maintain blinding, performed by a trained operator. Yes - There is a plan to make this available What will be shared: Individual Participant Data, Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analysis Codes, and Data Dictionary: The individual participant data (IPD) will include de-identified data on pain intensity (Visual Analog Scale scores), gingival index, inflammation, redness, and blisters, as well as demographic variables (age, gender) and pain catastrophizing scale scores. The study protocol will detail the methodology, including the split-mouth design, photobiomodulation parameters, and outcome assessments. The statistical analysis plan will describe the statistical tests (e.g., paired t-test, Wilcoxon, GEE) and software (SPSS) used. The informed consent form will be shared in its final approved version. The clinical study report will summarize findings post-study completion. Analysis codes will include SPSS syntax for all statistical analyses. The data dictionary will define all variables, their coding, and measurement units. When: Data and documents will be available starting six months after the publication of the primary study results and will remain accessible for five years thereafter. To whom: Researchers affiliated with academic or scientific institutions, including universities and research centers, who are conducting non-commercial research related to orthodontics, pain management, or photobiomodulation. Conditions: Data and documents may be used for secondary analyses, meta-analyses, or methodological reviews related to orthodontic pain management or photobiomodulation. Access requires a formal request outlining the research objectives, analysis plan, and ethical approval for the proposed study. Recipients must sign a data use agreement ensuring confidentiality, non-commercial use, and no attempt to re-identify participants. Data sharing will comply with ethical standards and Iranian regulations. Where to obtain: Requests should be submitted via email to Dr. Fatemeh Azizi at azizi3889@gmail.com. Alternatively, contact the Research Office at Kermanshah University of Medical Sciences, Shahid Beheshti Boulevard, Kermanshah, Iran, phone: +98 83 34276301. How to obtain: Applicants must submit a written request detailing the research purpose, analysis plan, and ethical approval. The request will be reviewed by the study’s principal investigator (Dr. Fatemeh Azizi) and the Kermanshah University of Medical Sciences Ethics Committee within four weeks. If approved, a data use agreement will be signed, and data/documents will be shared via a secure electronic platform within two weeks of agreement. Applicants will be notified of the decision and expected timeline. Comments: All shared data will be anonymized to protect participant privacy. The study team reserves the right to reject requests that do not align with the study’s ethical or scientific objectives. Shared data must not be redistributed without prior approval.
public Perham Shirvani
Afshin Johari Alley, Namaz Blvd, Niayesh Square
Kermanshah Iran (Islamic Republic of) 6715783197 +98 83 3421 8154 parham.shirvani@kums.ac.ir Kermanshah University of Medical Sciences scientific Perham Shirvani
Afshin Johari Alley, Namaz Blvd, Niayesh Square
Kermanshah Iran (Islamic Republic of) 6715783197 +98 83 3421 8154 parham.shirvani@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Patients requiring miniscrew placement during orthodontic treatment No prior orthodontic treatment before the study No radiographic evidence of bone loss No active dental caries No periodontal diseases Adequate oral hygiene no limit no limit Both Hypersensitivity to laser light Pregnancy Treatment - Devices Placebo Intervention group: Photobiomodulation therapy using a diode laser with a wavelength of 940 nanometers, power of 300 milliwatts, and energy density of 31.7 joules per square centimeter in continuous wave mode, applied for 180 seconds to the tissue surrounding the miniscrew on one side of the mouth. The laser is administered with a spot size of 1.7 square centimeters, moving from the surrounding tissue toward the center, by a trained operator. Control group: Placebo with an inactive laser applied for 180 seconds to the tissue surrounding the miniscrew on the opposite side of the mouth. The procedure mimics the active laser application in appearance, sound, and duration to maintain blinding, performed by a trained operator. Pain intensity following miniscrew placement in orthodontic treatment. Timepoint: Immediately after miniscrew placement, 1 hour after miniscrew placement, 12 hours after miniscrew placement, 24 hours after miniscrew placement. Method of measurement: Visual Analog Scale. Gingival inflammation around the miniscrew placement site as measured by the modified gingival index, scored as: 0 (no inflammation, pink gingiva, no visible biofilm), 1 (mild inflammation, red gingiva without bleeding), 2 (moderate inflammation, severe red gingiva with mild bleeding on probing), 3 (severe inflammation or miniscrew failure, pronounced bleeding, swelling). Timepoint: 7 days after miniscrew placement. Method of measurement: Modified Gingival Index. Presence of redness around the miniscrew placement site. Timepoint: 7 days after miniscrew placement. Method of measurement: Clinical examination by an orthodontist. Presence of blisters around the miniscrew placement site. Timepoint: 7 days after miniscrew placement. Method of measurement: Clinical examination by an orthodontist. Kermanshah University of Medical Sciences Approved 2025-05-13 Ethics Committee of Kermanshah University of Medical Sciences Ethics Committee, Medical Faculty, Daneshgah Street, Shahid Shiroodi Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)