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

Not Applicable

Completed

• Conditions: Malocclusion
• Interventions: Device: OrthoPulse™

• Registration Number: NCT02267837
• Lead Sponsor: Biolux Research Holdings, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-15
• Study First Posted: 2014-10-20
• Results First Submitted: 2015-08-12
• Results First Submitted QC: 2015-08-12
• Results First Posted: 2015-09-11
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.	Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.

Trial Locations

Locations (1)

Shaughnessy Orthodontics; 🇺🇸 Suwanee, Georgia, United States