Impact of Photobiomodulation on Pain During Orthodontic Treatment.

NCT05361616 | Completed

• 1 other identifier: Pro00112179
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to determine to effect of PBM Ortho, a photobiomodulation device, in adult patients undergoing clear aligners orthodontic treatment. We hypothesize that PBM Ortho will reduced the orthodontic associated pain in the clear aligner patients. This effect will be evaluated by recording the pain on visual analog scale given to the patients before the placement of clear aligners and collecting saliva.

Conditions

Malocclusion; Orthodontic Treatment

Keywords

photobiomodulation; clear aligners; orthodontic pain

Outcome Measures

Primary Outcomes (8)

• Visual analog scale

  Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement. Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale. Pain intensity does not have a unit to describe. The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.

  Day 0: prior to seating first clear aligner tray

• Visual analog scale

  Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement. Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale. Pain intensity does not have a unit to describe. The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.

  Day 1

• Visual analog scale

  Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement. Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale. Pain intensity does not have a unit to describe. The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.

  Day 2

• Visual analog scale

  Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement. Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale. Pain intensity does not have a unit to describe. The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.

  Day 3

• Visual analog scale

  Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement. Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale. Pain intensity does not have a unit to describe. The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.

  Day 4

• Visual analog scale

  Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement. Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale. Pain intensity does not have a unit to describe. The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.

  Day 5

• Visual analog scale

  Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement. Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale. Pain intensity does not have a unit to describe. The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.

  Day 6

• Visual analog scale

  Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement. Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale. Pain intensity does not have a unit to describe. The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.

  Day 7

Secondary Outcomes (4)

• Saliva analysis

  The saliva will be collected on Day 0

• Saliva analysis

  The saliva will be collected on Day 1

• Saliva analysis

  The saliva will be collected on Day 4

• Saliva analysis

  The saliva will be collected on Day 7

Study Arms (2)

PBM Ortho Active device

ACTIVE COMPARATOR

PBM Ortho Active group will be given an active device.

Device: PBM Ortho

PBM Ortho Sham

SHAM COMPARATOR

PBM Ortho Sham device group will be given a non-active device that will not emits light.

Device: PBM Ortho

Interventions

PBM Ortho DEVICE

The device will be used by the patients at home for one 8 minutes per day (4 minutes each upper and lower) for 7 days.

PBM Ortho Active device; PBM Ortho Sham

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy male and female patients (age 20 to 65), i.e., do not suffer from systemic illness nor require medication during the saliva collection period.
• Permanent dentition, with Little's Irregularity Index (LII) of 2 mm or greater for the upper and lower arch.
• Orthodontic treatment using clear aligners via non-extraction therapy.
• Patient is available for follow-up visits.
• Patient is able and willing to comply with the requirements of this trial protocol.
• Non-smoker with no use of chewing tobacco.
• Good oral hygiene.
• Caries free.
• No sign of periodontal disease.

You may not qualify if:

• Systemic diseases
• Medication use for the past 6 months; specially use of anti-inflammatory (e.g., NSAIDs), antiviral, antibiotics.
• Smoking.
• Active dental caries.
• Any periodontal problem including bleeding, tooth mobility, bone loss, attachment loss, deep pockets.
• Sleep apnea and other airway pathologies.

Sponsors & Collaborators

• PBM Healing International Limited: lead

Study Sites (2)

Sphinx Orthodontic

Edmonton, Alberta, T5K 2L2, Canada

Location

Orthodontic Graduate Clinic, Kaye Clinic, University of Alberta

Edmonton, Alberta, T6G 1Z1, Canada

Location

Related Publications (21)

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MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: May 4, 2022
• Study Start: April 17, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)