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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130521013406N6

Enrollment

Registered

2026-05-14

Start date

2025-09-23

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exophytic oral lesions. Exophytic oral lesions

Interventions

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 + Standa

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: adults aged ??–?? requiring excisional biopsy of exophytic oral lesions Lesion size: < ? cm × ? cm (measured with calipers) Willingness to attend follow-ups (days ? and ??)

Exclusion criteria

Exclusion criteria: 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 (<? weeks)

Design outcomes

Primary

Measure	Time frame
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 evalua	—

Measure

Time frame

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 evalua

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFahimeh Rezazadeh

Shiraz University of Medical Sciences

rezazadehf@sums.ac.ir+98 71 1628 9917

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026