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NCT Number: NCT07747350

Comparison Between the Effectiveness of Low-Grade Laser Therapy vs. Conventional Analgesics for Pain Reduction During Orthodontic Treatment in Malay Female Population

All patients will be treated using the fixed appliance on the upper and lower arches.

0.014" Niti(Nickel-Titanium) archwire is used to ensure all patients will receive the same force.

All participants will receive a pain diary. In the pain diary, they are required to complete a KAP(Knowledge, Attitudes, and Practices) questionnaire regarding pain before the procedure. They are also required to record the pain VAS (Visual Analog Scale) score at different times (before procedure, 6 hours, 12 hours, 24 hours, 3 days, 5 days and 7 days after procedure). For PCM (Paracetamol) 650mg group, 1 tablet will be given 1 hour before the procedure and every 6 hours for 24 hours (5 doses in total) as pain begins two hours after activation, peak at 24 hours and reduces after two days . Paracetamol if taken more than 4g per day may cause serious liver damage. United State of Food and Drugs Administration recently suggested a maximum daily dose of 3g to reduce risk of overdosing . Based on literature, 1000mg PCM(Paracetamol) is more efficient as postoperative analgesics 1000mg vs 650mg vs placebo. However, this study reported a single dose application (up to 6 hours). In view of continuous pain sensation experience by orthodontic patients (peak at 24 hours), we concluded that 650mg 6 hourly is more appropriate to control pain experienced by participants. For LLLT (Low-Level Laser Therapy) group: ezlase diode laser beam (Biolase, USA) for soft tissue operated at 940nm wavelength will be applied using a quadrant-sized probe that covers region form central incisor to first molar at the level of cervical third of the root, perpendicular and in light, direct contact with the buccal and palatal mucosa for the upper arch and buccal and lingual mucosa for the lower arch from UR6-UL6 and LR6- LL6 for 30 seconds each site . Patients will be monitored up to 1 hour after the LLLT ( Low-Level Laser Therapy) application for any adverse reactions. All procedures will be conducted in the morning session from 9am- 11am. Due to variability of pain experienced throughout the day , patients are advised to record pain in the morning to reduce the variability in VAS (Visual Analog Scale) score.

All the procedures and baseline score will also be conducted and recorded in the morning.

During the follow-up appointment (1 month after bond-up) Patients are required to re-answer the KAP (Knowledge, Attitudes, and Practices) questionnaire (post bond-up) in the pain diary. Pain diary will be collected for data analysis.

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Key information

Conditions

Age range

18 year–33 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

School of Dental Sciences Universiti Sains Malaysia

Kota Bharu, KOTA BHARU, Malaysia

Location status: Recruiting

Location contact

School of Dental Sciences Universiti Sains Malaysia

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18- 33 years old
  • Malay
  • Female
  • Fit and Healthy
  • New patients who have not received any orthodontic treatment

Exclusion criteria

  • Patient with a history of pain and medical problem
  • Patient who had taken medication for the past 2 weeks before orthodontic treatment
  • Patient with craniofacial deformities

Treatment and study plan

Low-level laser therapy (LLLT)

Device

Low-level laser therapy (LLLT) will be applied to the target teeth and buccal/lingual gingival tissues immediately after orthodontic archwire placement or adjustment to evaluate its effectiveness in reducing orthodontic pain

Other names: Low-Level Laser Application

Conventional Analgesic (Paracetamol)

Drug

Oral administration of conventional analgesics (e.g., Paracetamol) as needed for orthodontic pain relief after archwire placement

Other names: analgesic

Primary outcomes

  1. Pain Intensity Score

    Time frame: Assessed at 6, 12, 24, 48, and 72 hours following archwire placement

    Pain evaluated using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain)

  2. Orthodontic Pain Score

    Time frame: Assessed at 6, 12, 24, 48, and 72 hours following archwire placement

    Pain evaluated using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain)

Study contacts

Contact information is provided by the study sponsor or research team.

ROA RAAD FADHEL, MSc STUDENT

CONTACT

[email protected]

009647705371701

Sponsors and collaborators

Lead sponsor

ROA RAAD FADHEL

Other

Registry information

Acronym: LLTvsANALG

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 5, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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