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

NCT03202355 | Terminated FDA Device

• 1 other identifier: BX11
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Malocclusion

Keywords

Alignment phase; Photobiomodulation; Orthodontic treatment; Malocclusion; OrthoPulse™

Outcome Measures

Primary Outcomes (1)

• Rate of tooth movement in OrthoPulse treated and non-OrthoPulse treated patients

  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.

  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.

Secondary Outcomes (2)

• Effect of OrthoPulse PBM on external apical root resorption (EARR)

  6 months after the start of orthodontic treatment

• 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

Study Arms (2)

Group 1 (Control)

EXPERIMENTAL

Subjects assigned to this group receive fixed appliance orthodontic treatment only

Device: Fixed Appliance Orthodontic Treatment

Group 2 (OP1)

EXPERIMENTAL

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

Device: Fixed Appliance Orthodontic Treatment; Device: OrthoPulse™

Interventions

Fixed Appliance Orthodontic Treatment DEVICE

Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.

Group 1 (Control); Group 2 (OP1)

OrthoPulse™ DEVICE

Patients carry out daily OrthoPulse™ treatments at home.

Group 2 (OP1)

Eligibility Criteria

• Age: 11 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biolux Research Holdings, Inc.: lead

Study Sites (3)

Dickerson Orthodontics

Chandler, Arizona, 85224, United States

Location

Dickerson Orthodontics

Peoria, Arizona, 85382, United States

Location

Dickerson Orthodontics

Phoenix, Arizona, 85028, United States

Location

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MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Peter Brawn, DDS

  Biolux Research Holdings, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a two-arm, parallel, open-label, non-randomized, controlled, private practice study designed to evaluate the intended purposes of the investigation.

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 28, 2017
• Study Start: April 20, 2017
• Primary Completion: March 11, 2019
• Study Completion: March 11, 2019
• Last Updated: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)