Orthodontic PainLLTvsANALGNCT07747350
Comparison Between the Effectiveness of Low-Grade Laser Therapy vs. Conventional Analgesics for Pain Reduction During Orthodontic Treatment in Malay Female Population
A study testing Low-Level Laser Therapy (LLLT) and Conventional Analgesic (Paracetamol) in people with Orthodontic Pain, run by ROA RAAD FADHEL at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 33 years, women only
- Conditions the study is for
- Orthodontic Pain
- What is being tested?
- Low-Level Laser Therapy (LLLT) and Conventional Analgesic (Paracetamol)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Feb 2026to 20 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 33 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18- 33 years old
- Malay
- Female
- Fit and Healthy
- New patients who have not received any orthodontic treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
School of Dental Sciences Universiti Sains Malaysia
Kota Bharu, KOTA BHARU
School of Dental Sciences Universiti Sains Malaysia, ROUA19918@GMAIL.COM
About this study
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.
Read more
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.
- Conditions
- Orthodontic Pain
- Being tested
- Low-Level Laser Therapy (LLLT), Conventional Analgesic (Paracetamol)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser Therapy (LLLT)Device
Also called Low-Level Laser Application
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
Conventional Analgesic (Paracetamol)Drug
Also called analgesic
Oral administration of conventional analgesics (e.g., Paracetamol) as needed for orthodontic pain relief after archwire placement
| Study group | Role | What they receive |
|---|---|---|
| Low Level Laser Therapy Group | Experimental | Participants in this group will receive Low-Level Laser Therapy (LLLT) following orthodontic archwire placement or adjustment to evaluate its effectiveness in reducing orthodontic pain Receives: Device: Low-Level Laser Therapy (LLLT) |
| Conventional Analgesics Group | Active comparator | Participants in this group will receive conventional oral analgesics (e.g., Paracetamol) for pain relief following orthodontic activation Receives: Drug: Conventional Analgesic (Paracetamol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Score
Pain evaluated using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain)
Measured: Assessed at 6, 12, 24, 48, and 72 hours following archwire placement
Orthodontic Pain Score
Pain evaluated using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain)
Measured: Assessed at 6, 12, 24, 48, and 72 hours following archwire placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Feb 2026
- Primary completion1 Feb 2026
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ROA RAAD FADHEL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ROA RAAD FADHEL, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747350
- Sponsor's protocol ID
- USM/JEPeM/22110686
- Acronym
- LLTvsANALG
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effectiveness of Low-Grade Laser Therapy vs. Conventional Analgesics for Pain Reduction During Orthodontic Treatment in Malay Female Population
- ClinicalTrials.gov ID
- NCT07747350
- Acronym / sponsor ID
- LLTvsANALG / USM/JEPeM/22110686
- Conditions
- Orthodontic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ROA RAAD FADHELUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Level Laser Therapy Group | Experimental | Device: Low-Level Laser Therapy (LLLT)Participants in this group will receive Low-Level Laser Therapy (LLLT) following orthodontic archwire placement or adjustment to evaluate its effectiveness in reducing orthodontic pain |
| Conventional Analgesics Group | Active comparator | Drug: Conventional Analgesic (Paracetamol)Participants in this group will receive conventional oral analgesics (e.g., Paracetamol) for pain relief following orthodontic activation |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18- 33 years old
- Malay
- Female
- Fit and Healthy
- New patients who have not received any orthodontic treatment
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Level Laser Therapy (LLLT)Also: Low-Level Laser ApplicationLow-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 | Device | Low Level Laser Therapy Group |
| Conventional Analgesic (Paracetamol)Also: analgesicOral administration of conventional analgesics (e.g., Paracetamol) as needed for orthodontic pain relief after archwire placement | Drug | Conventional Analgesics Group |
Primary outcome
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy (LLLT) and Conventional Analgesic (Paracetamol) in people with Orthodontic Pain, run by ROA RAAD FADHEL at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ROA RAAD FADHEL, MSc STUDENT (009647705371701, roua19918@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Score (time frame: Assessed at 6, 12, 24, 48, and 72 hours following archwire placement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.