Impact of Photobiomodulation on Pain During Orthodontic Treatment.

PBM Healing

Status: Completed

Conditions: Orthodontic Treatment; Malocclusion

Treatments: Device: PBM Ortho

Study type: Interventional

Funder types: Industry

Identifiers

NCT05361616

Pro00112179

Details and patient eligibility

About

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.

Full description

Pain associated with orthodontic treatment is one of the main causes of treatment discontinuation and patient non-cooperation. Several treatment modalities have been studied to alleviate orthodontic pain which includes pharmacological, mechanical, and behavioral approach. One potential treatment is the application of photobiomodulation (PBM) therapy which is a form of light therapy. The objective of this study is to determine to effect of PBM therapy in adult patients undergoing clear aligners orthodontic treatment. 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. The patients will be provided with active PBM Ortho device and sham PBM device (placebo, which will look similar to the active device) to use them at home for one 8 minutes application for 7 days (4 minutes per arch, upper or lower). The pain scale sheets will also be given to the patients to fill them every day for 7 days. The inflammatory protein associated with pain present in the saliva will be collected on Day 1 (24 hours after clear aligner treatment start), Day 4 (fourth day of treatment), and Day 7 (after 1 week from the treatment start). On the last visit, the device and pain scale sheets will be collected from the patients. If successful, this device therapy will reduce the orthodontic associated pain and improve patients' compliance and cooperation.

Enrollment: 32 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups

PBM Ortho Active device

Active Comparator group

Description:

PBM Ortho Active group will be given an active device.

Treatment:

Device: PBM Ortho

PBM Ortho Sham

Sham Comparator group

Description:

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

Treatment:

Device: PBM Ortho