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IRCT20260614069786N1 IRCT 2026-07-06 Tehran University of Medical Sciences Does photobiomodulation with a 970-nm diode laser and neutral gel reduce pain during local anesthetic injection in maxillary anterior teeth? Evaluation of the effect of 970-nm diode laser photobiomodulation combined with a neutral gel on pain perception during buccal infiltration anesthesia in maxillary anterior teeth 2026-07-06 anticipated 128 Recruiting https://irct.ir/trial/90856 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly allocated to one of the four study groups using variable block randomization with block sizes of 4 and 8. The random allocation sequence will be generated by an independent statistician. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes (SNOSE), Blinding description: Participants will be blinded to active versus sham laser allocation. Due to the nature of the intervention, operator blinding is not feasible. N/A Patients requiring buccal infiltration local anesthesia in the anterior maxillary region for dental procedures. Intervention 1: Intervention group: Participants will receive photobiomodulation using a 970-nm diode laser (Sirolaser Blue, Sirona Dental Systems GmbH, Germany) with a power output of 1.5 W in continuous-wave mode and an 800-µm fiber tip. Laser irradiation will be applied to the injection site for approximately 10–25 seconds. Standard buccal infiltration anesthesia will then be administered immediately. Intervention 2: Intervention group: A neutral gel without active ingredients will be applied to the injection site for one minute and subsequently removed. Sham laser application will then be performed using the same device appearance, sounds, aiming beam, duration, and positioning as active laser treatment, but without therapeutic energy emission. Standard buccal infiltration anesthesia will then be administered. Intervention 3: Intervention group: A neutral gel will be applied to the injection site for one minute. Active photobiomodulation with a 970-nm diode laser will then be delivered using the same parameters described for Group 1. The gel will subsequently be removed, and standard buccal infiltration anesthesia will be administered. Intervention 4: Control group: Participants will receive sham laser treatment without gel application, followed by standard buccal infiltration anesthesia. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is This study is still in the data collection phase and has not yet been completed. Therefore, the decision regarding the sharing of participants’ raw data will be made after the study is finished and data analysis is completed.
public Nazanin Mohamadi
School of Dentistry, Tehran University of Medical Sciences (TUMS) North Kargar Street (End), Tehran
Tehran Iran (Islamic Republic of) 1439955991 +98 21 4279 4000 nazaninmohammadi200@gmail.com Tehran University of Medical Sciences scientific Nazanin Mohamadi
School of Dentistry, Tehran University of Medical Sciences (TUMS) North Kargar Street (End), Tehran
Tehran Iran (Islamic Republic of) 1439955991 +98 21 4279 4000 nazaninmohammadi200@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Adults aged 18 years and older. Patients requiring buccal infiltration anesthesia in the maxillary anterior region for dental treatment. American Society of Anesthesiologists (ASA) physical status I or II. Ability to understand and complete the Visual Analog Scale (VAS) and Dental Anxiety Inventory (DAI). Provision of written informed consent. 18 years no limit Both Lack of informed consent to participate in the study. Known allergy to local anesthetic agents or contraindication to the use of epinephrine. Uncontrolled systemic disease requiring specialized medical management. Presence of inflammation, infection, abscess, wound, or any soft tissue lesion at the injection site. Use of analgesics/NSAIDs, corticosteroids, sedatives, or anti-anxiety medications within 24 hours prior to the intervention. Alcohol or stimulant substance use within the previous 24 hours. Patients with acute dental pain, swelling, or requiring emergency dental treatment. R52 Pain, unspecified Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group: Participants will receive photobiomodulation using a 970-nm diode laser (Sirolaser Blue, Sirona Dental Systems GmbH, Germany) with a power output of 1.5 W in continuous-wave mode and an 800-µm fiber tip. Laser irradiation will be applied to the injection site for approximately 10–25 seconds. Standard buccal infiltration anesthesia will then be administered immediately. Intervention group: A neutral gel without active ingredients will be applied to the injection site for one minute and subsequently removed. Sham laser application will then be performed using the same device appearance, sounds, aiming beam, duration, and positioning as active laser treatment, but without therapeutic energy emission. Standard buccal infiltration anesthesia will then be administered. Intervention group: A neutral gel will be applied to the injection site for one minute. Active photobiomodulation with a 970-nm diode laser will then be delivered using the same parameters described for Group 1. The gel will subsequently be removed, and standard buccal infiltration anesthesia will be administered. Control group: Participants will receive sham laser treatment without gel application, followed by standard buccal infiltration anesthesia. Pain induced by local anesthesia injection. Timepoint: Pain upon needle penetration (immediately after needle insertion into the mucosa and before anesthetic injection) and Pain during injection (immediately after completion of anesthetic solution injection). Method of measurement: Pain intensity will be measured using the Visual Analog Scale (VAS). Dental anxiety level. Timepoint: before the intervention. Method of measurement: Dental Anxiety Inventory (DAI) questionnaire. Tehran University of Medical Sciences Approved 2026-06-14 Research Ethics Committees of School of Dentistry- Tehran university of Medical Science Faculty of Dentistry, Tehran University of Medical Sciences End of North Kargar Street, beside the Atomic Energy Organization of Iran, Before the East Hakim Expressway Exit, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)