The Effect of OrthoPulse Photobiomodulation on the Rate of Tooth Movement During Alignment With Fixed Appliances

Not Applicable

Terminated

• Conditions: Malocclusion
• Interventions: Device: Fixed Appliance Orthodontic Treatment; Device: OrthoPulse™

• Registration Number: NCT03202355
• Lead Sponsor: Biolux Research Holdings, Inc.

Brief Summary

The aim of this study is to determine efficacy of OrthoPulse photobiomodulation on the rate of tooth movement during alignment for Subjects receiving fixed appliance orthodontic treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-20
• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-28
• Primary Completion: 2019-03-11
• Study Completion: 2019-03-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Presence of permanent dentition
• Eligible and scheduled for full-mouth, fixed-appliance orthodontic treatment
• Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth
• Class I or Class II malocclusion by ½ cusp or less
• Non-extraction in both arches
• Age 11-60
• Good oral hygiene
• Non-smoker; non-use of chewing tobacco

Exclusion Criteria

• Subject is currently enrolled in another clinical study
• Subject decided on Invisalign rather than braces
• Periodontally involved teeth
• Use of bisphosphonates (osteoporosis drugs) during the study
• Subject plans to relocate over the treatment period
• Spaces between anterior teeth
• Subject has dental implants or an implanted prosthesis
• Sponsor employees, the Investigator and staff, as well as their immediate family members

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Control)	Fixed Appliance Orthodontic Treatment	Subjects assigned to this group receive fixed appliance orthodontic treatment only
Group 2 (OP1)	Fixed Appliance Orthodontic Treatment	Subjects assigned to this group receive fixed appliance orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Group 2 (OP1)	OrthoPulse™	Subjects assigned to this group receive fixed appliance orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.

Primary Outcome Measures

Name	Time	Method
Rate of tooth movement in OrthoPulse treated and non-OrthoPulse treated patients	From start of treatment until Little's Irregularity Index (LII) reaches less than approximately 2 mm but greater than 0 mm, no more than 6 months after the start of treatment.	Rate of tooth movement will be evaluated based on the duration of time and amount of tooth movement required to reach Little's Irregularity Index (LII) of less than approximately 2 mm but greater than 0 mm, as determined by the qualified investigator.

Secondary Outcome Measures

Name	Time	Method
Risk of OrthoPulse PBM to the patient.	Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case	Patients from both groups will be questioned and assessed at regularly scheduled visits for treatment-related adverse events.
Effect of OrthoPulse PBM on external apical root resorption (EARR)	6 months after the start of orthodontic treatment	Root lengths from patients will be measured using panoramic radiographs at the start of treatment and 6 months after the start of treatment. These measurements will be used to determine and compare EARR between each of the two groups.

Trial Locations

Locations (1)

Dickerson Orthodontics; 🇺🇸 Phoenix, Arizona, United States