OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study

Biolux Research

Status: Completed

Conditions: Malocclusion

Treatments: Device: OrthoPulse™

Study type: Interventional

Funder types: Industry

Identifiers

NCT02267837

TS1.5

Details and patient eligibility

About

The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on the rate of anterior orthodontic alignment.

Enrollment: 20 patients

Sex: All

Ages: 11 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of permanent dentition
• Eligible and scheduled for full mouth fixed orthodontic treatment
• Class I or Class II malocclusion (no more than ½ cusp in Class II)
• Non-extraction in all quadrants
• Non-smoker
• Good oral hygiene as determined by the investigator
• No adjunct treatment such as extra- or intra-oral appliances

Exclusion criteria

• Pregnant females
• Patient is currently enrolled in another clinical study
• Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable)
• Periodontally involved teeth
• Use of bisphosphonates
• Unerupted or partially erupted maxillary teeth
• Teeth blocked out of alignment and unable to engage initial arch wire
• Spaces present in the maxillary arch

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

OrthoPulse™

Experimental group

Description:

Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.

Treatment:

Device: OrthoPulse™

Control

No Intervention group

Description:

Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.