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Effect of Photobiomodulation on Pain Reduction During Orthodontic Band Placement

Evaluation of the Effect of Diode Laser Photobiomodulation on Pain Intensity in Patients During Orthodontic Band Placement: A Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250528065948N1
Enrollment
22
Registered
2025-06-05
Start date
2025-06-22
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Pain caused by the placement of orthodontic bands.

Interventions

Intervention 1: Intervention group: In the photobiomodulation side (active laser), a diode laser with a wavelength of 940 nanometers, power of 300 milliwatts, and energy density of 31.7 joules per squ

Sponsors

Dr. Golshah Dental Clinic
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients requiring orthodontic band placement on maxillary or mandibular molars Age 12 years or older Good general health without systemic diseases Informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Patients with active periodontal disease Use of analgesic or anti-inflammatory drugs within 48 hours before the study Presence of oral lesions or ulcers at the band placement site Patients with a history of hypersensitivity to laser therapy Pregnant patients

Design outcomes

Primary

MeasureTime frame
Perceived general pain intensity caused by the placement of orthodontic bands (measured by the Visual Analog Scale). Timepoint: 30 minutes before band placement (to adjust for baseline pain from elastomeric separators), 5 minutes, 1 hour, 12 hours, 24 hours, and 72 hours after band placement. Method of measurement: The Visual Analog Scale is a 10-centimeter horizontal line, graded from 0 (no pain) to 10 (unbearable pain). The patient marks the line to indicate pain intensity, and the score is measured by the researcher using a ruler.;Perceived pain intensity during teeth clenching caused by the placement of orthodontic bands (measured by the Visual Analog Scale). Timepoint: 30 minutes before band placement (to adjust for baseline pain from elastomeric separators), 5 minutes, 1 hour, 12 hours, 24 hours, and 72 hours after band placement. Method of measurement: The Visual Analog Scale is a 10-centimeter horizontal line, graded from 0 (no pain) to 10 (unbearable pain). The patient marks the line to indicate pain intensity, and the score is measured by the researcher using a ruler.;Perceived pain intensity during chewing caused by the placement of orthodontic bands (measured by the Visual Analog Scale). Timepoint: 30 minutes before band placement (to adjust for baseline pain from elastomeric separators), 5 minutes, 1 hour, 12 hours, 24 hours, and 72 hours after band placement. Method of measurement: The Visual Analog Scale is a 10-centimeter horizontal line, graded from 0 (no pain) to 10 (unbearable pain). The patient marks the line to indicate pain intensity, and the score is measured by the researcher using a ruler.

Secondary

MeasureTime frame
Presence or absence of tissue damage at the site of orthodontic band placement, including any visible wounds or abrasions in the oral soft tissues (gingiva or mucosa). Timepoint: 72 hours after the placement of orthodontic bands. Method of measurement: Visual inspection by an orthodontist using adequate lighting and standard examination tools (dental mirror and probe) to identify any wounds or abrasions in the oral soft tissues.;Presence or absence of tissue discoloration at the site of orthodontic band placement, including any abnormal color changes in the gingiva or mucosa (such as whitening or darkening). Timepoint: 72 hours after the placement of orthodontic bands. Method of measurement: Visual inspection by an orthodontist using adequate lighting and standard examination tools (dental mirror) to identify any abnormal color changes in the oral soft tissues.;Presence or absence of tissue irritation and redness at the site of orthodontic band placement, including visible inflammation or erythema in the gingiva or mucosa. Timepoint: 72 hours after the placement of orthodontic bands. Method of measurement: Visual inspection by an orthodontist using adequate lighting and standard examination tools (dental mirror and probe) to identify any inflammation or erythema in the oral soft tissues.;Presence or absence of blisters at the site of orthodontic band placement, including any visible blister-like lesions in the gingiva or mucosa. Timepoint: 72 hours after the placement of orthodontic bands. Method of measurement: Visual inspection by an orthodontist using adequate lighting and standard examination tools (dental mirror) to identify any blister-like lesions in the oral soft tissues.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKimia Kakaii

Kermanshah University of Medical Sciences

kimia.kakaii@kums.ac.ir+98 83 3421 8154

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026