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

Biolux Research

Status: Unknown

Conditions: Malocclusion

Treatments: Device: Invisalign (7 day); Device: OrthoPulse; Device: Invisalign (5 day); Device: Invisalign (3.5 day)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02954133

BX9

Details and patient eligibility

About

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.

Enrollment: 167 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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167 participants in 4 patient groups

I7: Control

Experimental group

Description:

Subjects assigned to this group receive no OrthoPulse™ treatment, and switch Invisalign aligners every 7 days.

Treatment:

Device: Invisalign (7 day)

OP7: OrthoPulse Treatment

Experimental group

Description:

Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 7 days.

Treatment:

Device: Invisalign (7 day)

Device: OrthoPulse

OP5: OrthoPulse Treatment

Experimental group

Description:

Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 5 days.

Treatment:

Device: OrthoPulse

Device: Invisalign (5 day)

OP3.5: OrthoPulse Treatment

Experimental group

Description:

Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 3.5 days.

Treatment:

Device: OrthoPulse

Device: Invisalign (3.5 day)