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Impact of Photobiomodulation on Pain During Orthodontic Treatment.

Malocclusion | Orthodontic Treatment

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    20 to 65

Participation Criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Study Location

Sphinx Orthodontic
Sphinx Orthodontic
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Tarek El-Bialy, PhD

[email protected]
7806953110
Orthodontic Graduate Clinic, Kaye Clinic, University of Alberta
Orthodontic Graduate Clinic, Kaye Clinic, University of Alberta
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Tarek El-Bialy, PhD

[email protected]
7806953110
Study Sponsored By
PBM Healing International Limited
Participants Required
More Information
Study ID: NCT05361616