The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment

Not Applicable

• Conditions: Malocclusion
• Interventions: Device: Invisalign (7 day); Device: Invisalign (5 day); Device: OrthoPulse; Device: Invisalign (3.5 day)

• Registration Number: NCT02954133
• Lead Sponsor: Biolux Research Holdings, Inc.

Brief Summary

The aim of the study is to determine if, and to what degree photobiomodulation treatment with OrthoPulse has an effect on the rate of tooth movement during alignment for patients receiving Invisalign orthodontic aligner treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-03
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-15
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

• Invisalign "Full Treatment" product only

• Have a permanent dentition

  • 18 years-old

• Angle Class I or ½ cusp Class II molar and canine relationship

• Moderate to mild crowding in at least one arch

Exclusion Criteria

• Subjects who do not fulfill all inclusion criteria requirements
• Craniofacial anomaly present
• Past or present signs and symptoms of periodontal disease
• A significant medical or medication history that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement
• Previous orthodontic or orthopedic relapse within 1 year
• History of trauma, bruxism, or parafunction
• Skeletal jaw discrepancy
• Use of osteoporosis drugs
• Initial use of auxiliary mechanics such as elastics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OP7: OrthoPulse Treatment	OrthoPulse	Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 7 days.
I7: Control	Invisalign (7 day)	Subjects assigned to this group receive no OrthoPulse™ treatment, and switch Invisalign aligners every 7 days.
OP5: OrthoPulse Treatment	Invisalign (5 day)	Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 5 days.
OP3.5: OrthoPulse Treatment	OrthoPulse	Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 3.5 days.
OP7: OrthoPulse Treatment	Invisalign (7 day)	Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 7 days.
OP5: OrthoPulse Treatment	OrthoPulse	Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 5 days.
OP3.5: OrthoPulse Treatment	Invisalign (3.5 day)	Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 3.5 days.

Primary Outcome Measures

Name	Time	Method
Rate of tooth movement	From date of enrolment until the date of completion of the last Invisalign aligner, assessed every 4-6 weeks up to 2 years	Tooth position will be measured at the end of aligners 6 (4-6 weeks), 12 (8-12 weeks), 18 (12-18 weeks), at the end first series of aligners at refinement, and at the end of treatment. Rates will be measured end of use of each individual Invisalign time point in order to determine whether the application of photobiomodulation increases the rate of tooth movement with Invisalign treatment.

Secondary Outcome Measures

Name	Time	Method
Length of treatment time	From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years	Treatment time will be calculated as the number of days from the first day until the last day the subject wears Invisalign aligners. To evaluate whether the application of photobiomodulation decreases the total treatment time with Invisalign treatment, the measured length of time will be compared against the expected treatment time.
Effect of photobiomodulation on external apical root resorption	From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years	Root lengths will be measured from panoramic radiographs to evaluate whether the application of photobiomodulation decreases the total amount of external apical root resorption over the course of the treatment,

Trial Locations

Locations (4)

Chenin Orthodontics; 🇺🇸 Henderson, Nevada, United States

Dickerson Orthodontics; 🇺🇸 Chandler, Arizona, United States

Kottemann Orthodontics; 🇺🇸 Maple Grove, Minnesota, United States

Orthodontic Associates; 🇺🇸 Oklahoma City, Oklahoma, United States