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IRCT20130521013406N6 IRCT 2026-05-14 Shiraz University of Medical Sciences Evaluation of 660-nm and 808-nm Laser Therapy for Reducing Microbial Load and Healing Oral Biopsy Wounds Comparison of the Effect of Two Wavelengths (660 nm and 808 nm) of Diode Laser (LLLT) on Bacterial Load and Healing of Oral Biopsy Site 2025-09-23 anticipated 30 Complete https://irct.ir/trial/85354 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be employed to ensure balance across age groups (۱۸–۴۰ vs. ۴۱–۶۵ years) and biopsy site locations. After selecting patients who met the inclusion criteria for the study and providing a complete explanation of the objectives of the research project, an informed consent form will be completed for all of them. Subsequently, patients will be divided into ۳ groups using random blocks of ۴. Group A will receive a placebo (sham laser) group B will be received ۶۶۰ nm lased and group C will be received ۸۰۸ nm laser, Blinding description: Participants will be blinded through the use of a sham laser device that mimics the appearance and sound of the active laser units but emits no therapeutic light. clinical evaluators will remain blinded to group allocation. N/A Exophytic oral lesions. Intervention 1: Intervention group: 660 nm diode laser therapy (100 milliwatt, 4 joules/cm² energy density, continuous wave mode, 60 seconds per site) using XYZ Medical Lasers Model LLLT-3000 + Standard care (normal saline rinse). Intervention 2: Intervention group: 808 nm diode laser therapy (100 milliwatt, 4 joules/cm² energy density, continuous wave mode, 60 seconds per site) using XYZ Medical Lasers Model LLLT-3000 + Standard care (normal saline rinse). Intervention 3: Control group: Sham laser (inactive device: XYZ Medical Lasers Model LLLT-3000) + Standard care (0.9% normal saline mouth rinse twice daily for 7 days post-biopsy). 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 there is no further information
public Fahimeh Rezazadeh
Iran-shiraz-dental school-oral medicine department
Shiraz Iran (Islamic Republic of) 71956-15878 +98 71 1628 9917 rezazadehf@sums.ac.ir Shiraz University of Medical Sciences scientific Fahimeh Rezazadeh
Iran-shiraz-dental school-oral medicine department
Shiraz Iran (Islamic Republic of) 71956-15878 +98 71 1628 9917 rezazadehf@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) adults aged ۱۸–۶۵ requiring excisional biopsy of exophytic oral lesions Lesion size: < ۲ cm × ۲ cm (measured with calipers) Willingness to attend follow-ups (days ۷ and ۱۴) 18 years 65 years Both History of oral cancer, lupus, epilepsy, or pregnancy Immunosuppression (HIV, chemotherapy, corticosteroids) systemic diseases impairing healing (e.g., uncontrolled diabetes) Recent antibiotic/anti-inflammatory use (<۴ weeks) Exophytic oral lesions Treatment - Devices Treatment - Devices Treatment - Devices Intervention group: 660 nm diode laser therapy (100 milliwatt, 4 joules/cm² energy density, continuous wave mode, 60 seconds per site) using XYZ Medical Lasers Model LLLT-3000 + Standard care (normal saline rinse). Intervention group: 808 nm diode laser therapy (100 milliwatt, 4 joules/cm² energy density, continuous wave mode, 60 seconds per site) using XYZ Medical Lasers Model LLLT-3000 + Standard care (normal saline rinse). Control group: Sham laser (inactive device: XYZ Medical Lasers Model LLLT-3000) + Standard care (0.9% normal saline mouth rinse twice daily for 7 days post-biopsy). Primary Outcome Variable 1: Bacterial load at the biopsy site (colony-forming units per milliliter). This outcome measures the quantitative change in bacterial presence at the biopsy site over time. Bacterial load is assessed through sterile swab sampling followed by aerobic and anaerobic culture. The number of colony-forming units per milliliter is calculated using serial dilution plating on blood agar and incubated at 37°C for 24 to 48 hours. A decrease in CFU/mL over time is interpreted as effective bacterial reduction due to the intervention. Timepoint: Bacterial load (colony-forming units per milliliter): Measured at three time points: Before the start of laser therapy (baseline), Immediately after completion of laser therapy, Seven days after the biopsy procedure. Method of measurement: Sterile swab sampling from the biopsy site; culture on blood agar under aerobic and anaerobic conditions; colony-forming units per milliliter determined by serial dilution plating. Incubation is performed at 37 degrees Celsius for 24 to 48 hours before bacterial quantification./. Primary Outcome Variable 2: Clinical wound healing score based on the Early Healing Score outcome evaluates the clinical healing process at the biopsy site using the Early Healing Score, a validated composite index. It includes three components: re-epithelialization, hemostasis, and inflammation. Each component is scored separately and summed to produce a total score ranging from 0 (poor healing) to 10 (ideal healing). The assessment is performed at multiple time points by a blinded clinical evaluator. Timepoint: Wound healing score (Early Healing Score): Measured at three time points: Immediately after laser therapy Seven days after the biopsy Fourteen days after the biopsy. Method of measurement: Clinical assessment form based on the Early Healing Score index, evaluating three parameters: re-epithelialization, hemostasis, and inflammation. Scoring is performed by a trained and blinded clinical evaluator using a validated wound healing scale. Secondary Outcome Variable 1: Postoperative pain intensity measured by Visual Analogue Scale (VAS)Postoperative pain will be measured using the Visual Analogue Scale, a 100-mm horizontal line anchored at each end by descriptors: "no pain" (0 mm) on the left and "worst imaginable pain" (100 mm) on the right. Patients will mark the point that best represents their perceived pain intensity, and the distance in millimeters from the left end will be recorded. Pain assessments will be conducted at baseline (before treatment) and on postoperative days 1, 3, 7, and 14. Timepoint: For postoperative pain (Visual Analogue Scale): Before intervention (baseline), Postoperative day 1, Postoperative day 3, Postoperative day 7, Postoperative day 14. Method of measurement: Visual Analogue Scale: a 100-mm horizontal line anchored at each end by descriptors: "no pain" (0 mm) on the left and "worst imaginable pain" (100 mm) on the right. Patients will mark the point that best represents their perceived pain intensity, and the distance in millimeters from the left end will be recorded. Pain assessments will be conducted at baseline (before treatment) and on postoperative days 1, 3, 7, and 14. Secondary Outcome Variable 2: Patient satisfaction with wound healing measured by a 5-point Likert scale. Timepoint: Patient satisfaction regarding the wound healing process will be assessed on postoperative day 14 using a 5-point Likert scale. Method of measurement: Participants will choose one of the following options = Very dissatisfied, 2 = Dissatisfied, 3 = Neutral, 4 = Satisfied, 5 = Very satisfied. Results will be reported as the percentage of participants in each category, particularly those selecting “satisfied” or “very satisfied,” across the three study groups. Shiraz University of Medical Sciences Approved 2026-05-10 Ethics committee of Shiraz University of Medical Sciences Central building of Shiraz University of Medical Sciences Zand St. Shiraz Fars Iran (Islamic Republic of)