Compare the effects of ۶۶۰ nm and ۸۰۸ nm diode laser LLLT on reducing bacterial load and enhancing clinical wound healing in intraoral biopsy sites.
Design
A randomized, double-blind, parallel-group clinical trial with a control arm involving 30 patients. Block randomization was used for allocation.
Settings and conduct
Location: Department of Oral Medicine, Shiraz University of Medical Sciences
Population: Adults aged 18–65 with exophytic oral lesions (<2×2 cm)
Procedure:
Excisional biopsy under local anesthesia
Block randomization (blocks of 4), stratified by age and biopsy site
Follow-ups on days 7 and 14 to assess bacterial load and wound healing score (EHS)
Blinding:
Participants blinded using a sham laser device
Laser operator and clinical/microbial outcome assessors blinded to group allocation
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
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).
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 (<۴ weeks).
Intervention groups
Group A: Standard care + sham laser
Group B: Standard care + 660 nm LLLT
Group C: Standard care + 808 nm LLLT
Main outcome variables
Reduction of bacterial load at three time points (baseline, immediately after laser therapy, and 7 days post-biopsy) measured in CFU/mL; clinical wound healing assessment using the Early Healing Score (EHS) at the same time points.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130521013406N6
Registration date:2026-05-14, 1405/02/24
Registration timing:registered_while_recruiting
Last update:2026-05-14, 1405/02/24
Update count:0
Registration date
2026-05-14, 1405/02/24
Registrant information
Name
Fahimeh Rezazadeh
Name of organization / entity
Dental school of shiraz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 71 1628 9917
Email address
rezazadehf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2026-09-23, 1405/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of 660-nm and 808-nm Laser Therapy for Reducing Microbial Load and Healing Oral Biopsy Wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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)
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 (<۴ weeks)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences Zand St.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2026-05-10, 1405/02/20
Ethics committee reference number
IR.SUMS.REC.1405.125
Health conditions studied
1
Description of health condition studied
Exophytic oral lesions
ICD-10 code
ICD-10 code description
Exophytic oral lesions
Primary outcomes
1
Description
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./
2
Description
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 outcomes
1
Description
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.
2
Description
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.
Intervention groups
1
Description
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).
Category
Treatment - Devices
2
Description
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).
Category
Treatment - Devices
3
Description
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).
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Fahimeh Rezazadeh
Street address
Ghasrodasht St., Mehr Ave.
City
Shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 71 3626 3193
Email
dental@sums.ac.ir
Web page address
https://dental.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Street address
Ghasrodasht St., Mehr Ave.
City
Shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 71 3626 3193
Email
dental@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Rezazadeh
Position
Associate Professor of Oral & Maxillofacial Medicine
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Iran-shiraz-dental school-oral medicine department
City
Shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 71 1628 9917
Fax
+98 71 1626 3193
Email
rezazadehf@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Rezazadeh
Position
Associate Professor of Oral & Maxillofacial Medicine
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Iran-shiraz-dental school-oral medicine department
City
Shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 71 1628 9917
Fax
+98 71 1626 3193
Email
rezazadehf@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Rezazadeh
Position
Associate Professor of Oral & Maxillofacial Medicine
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Iran-shiraz-dental school-oral medicine department
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 1628 9917
Fax
+98 71 1626 3193
Email
rezazadehf@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available