The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement

Malocclusion Clinical Trial

— BX8RN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267811
• Other study ID #: BX8RN
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: June 2016

Study information

• Verified date: May 2019
• Source: Biolux Research Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This open label study is designed to evaluate the ability of OrthoPulse™ to safely and effectively increase the rate of orthodontic tooth movement with fixed appliances.

Description:

The primary aim of this study is to determine if daily OrthoPulse™ use affects the rate of orthodontic tooth movement during alignment with fixed appliances in the mandibular arch.

The secondary aim of this study is to determine whether patients treated with OrthoPulse demonstrate root resorption beyond what is commonly expected during orthodontic treatment.

The study also aims to collect confirmatory evidence on the safety of the device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 60 Years

Eligibility

Inclusion Criteria:

• Eligible and scheduled for full mouth fixed orthodontic treatment

• Moderate to severe crowding (LII = 3 mm), with no labio-lingually displaced teeth

• Class I or Class II by 1/2 cusp or less

• Non-extraction in both arches

• Age 11- 60

• Good oral hygiene

• Non-smokerInclud

Exclusion Criteria:

• Pregnant females

• Patient is currently enrolled in another clinical study

• Patient decided on Invisalign® rather than braces

• Periodontally involved teeth

• Use of bisphosphonates (osteoporosis drugs) during the study

• Patient plans to move over the treatment period

• Spaces between anterior teeth

Related Conditions & MeSH terms

• Malocclusion

Intervention

Other:
• Orthodontic Treatment
Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.

Device:
• OrthoPulse™
Participants carry out daily OrthoPulse™ treatments at home.

Locations

Country	Name	City	State
United States	Stone Oak Orthodontics	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Biolux Research Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment	Rate of participants orthodontic tooth movement using Little's Index of Irregularity (LII) measured in millimeters per week during alignment.	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.
Secondary	Safety Evidence of OrthoPulse™ Use	The number of significant adverse events reported from time of participant enrolment to study completion for all study participants	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.
Secondary	Degree of External Apical Root Resorption (EARR)	The amount of EARR experienced as assessed at six (6) months or later after starting treatment. External Apical Root Resorption can result from orthodontic tooth movement. External apical root resorption is the shortening of the root and affects root surface(s), which can result in loss of tooth structure. External apical root resorption is being determined in this study by comparing root lengths from initial to six (6) months or later after starting treatment. The measurements are taken from the crown to the root apex in millimeters.; A positive number under the measure of dispersion signifies root resorption.	Assessed at six (6) months or later after starting treatment, up to two (2) years.