OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical Effectiveness (CA)

Orthodontic Tooth Movement Clinical Trial

Official title:

RI.2 OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04386278
• Other study ID #: RI.2
• Status: Terminated
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: June 24, 2020

Study information

• Verified date: November 2020
• Source: Biolux Research Holdings, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, interventional, non-randomized, control, split-mouth, open-label, single centre, private practice study aimed to evaluate the effect of tooth movement during orthodontic treatment using a removeable thermoplastic orthodontic appliance. Intrusion and extrusion will be conducted using bilaterally equivalent elastomeric forces of 50 grams.

A comparison of the rate of bilateral orthodontic tooth movement will be conducted using six (6) varied photobiomodulation interventions on the maxillary (upper) and mandibular (lower) arches. The OrthoPulse Gen 2 and OrthoPulse (commercially approved) devices are being used in this clinical investigation. Each subject enrolled will go through intrusion and extrusion.

All subjects will be allocated to an OrthoPulse split-mouth intervention by the investigator.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: June 24, 2020
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patient must be 19 years of age or older

• Likely to be compliant to OrthoPulse use, aligner wear, and Dental Monitoring scanning

• Have a compatible iOS or Android device and are willing to download the OrthoPulse and Dental Monitoring apps for frequent automatic syncing of data

Exclusion Criteria:

• Patient is currently enrolled in another clinical study

• Crowding or rotations of bilateral bicuspids that would prevent or interfere with intrusion

• Periodontally involved teeth, acute oral infection or periodontal disease

• Patient has active/untreated caries

• Use of bisphosphonates at any time

• Use of drugs that may cause photosensitivity

• History of photosensitivity

• Epilepsy

• Pregnant or planning pregnancy during the study.

• Patient plans to relocate over the treatment period

Related Conditions & MeSH terms

• Orthodontic Tooth Movement

Intervention

Device:
• Intervention 1
Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute
• Intervention 2
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute
• Intervention 3
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes
• Intervention 4
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes
• Intervention 5
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
• Intervention 6
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes
• Intervention 7
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
• Intervention 8
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RBP) for five minutes

Locations

Country	Name	City	State
Canada	Dr. Peter Brawn	Vancouver	B.C

Sponsors (1)

Lead Sponsor	Collaborator
Biolux Research Holdings, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of orthodontic tooth movement	The rate of orthodontic tooth movement during intrusion at 36 days (±12 days) from the T0 Visit (measured in mm per week).	36 days (±12 days) from T0 visit
Secondary	Peak Pain: Questionnaire	Assess peak pain experienced over first seven (7) days of treatment during intrusion using a questions similar in nature to a Visual Analog Scale (subject to complete pain questionnaire).	7 Days
Secondary	Root Resorption	Assess tooth resorption by measuring the root length of the first or second bicuspid bilaterally from baseline to T3	36 days (±12 days) from T0 visit
Secondary	Initial Safety of Device	Confirmation of safety through collection of adverse events	From enrolment to study completion, anticipated six (6) months