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

NCT04386278 | Terminated

• 1 other identifier: RI.2
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthodontic Tooth Movement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Peak Pain: Questionnaire

  7 Days

• Root Resorption

  36 days (±12 days) from T0 visit

• Initial Safety of Device

  From enrolment to study completion, anticipated six (6) months

Study Arms (8)

Intervention 1

EXPERIMENTAL

Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute

Device: Intervention 1

Intervention 2

EXPERIMENTAL

Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute

Device: Intervention 2

Intervention 3

EXPERIMENTAL

Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes

Device: Intervention 3

Intervention 4

EXPERIMENTAL

Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes

Device: Intervention 4

Intervention 5

EXPERIMENTAL

Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute

Device: Intervention 5

Intervention 6

EXPERIMENTAL

Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes

Device: Intervention 6

Intervention 7

EXPERIMENTAL

Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute

Device: Intervention 7

Intervention 8

EXPERIMENTAL

Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes

Device: Intervention 8

Interventions

Intervention 1 DEVICE

Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute

Intervention 1

Intervention 2 DEVICE

Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute

Intervention 2

Intervention 3 DEVICE

Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes

Intervention 3

Intervention 4 DEVICE

Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes

Intervention 4

Intervention 5 DEVICE

Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute

Intervention 5

Intervention 6 DEVICE

Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes

Intervention 6

Intervention 7 DEVICE

Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute

Intervention 7

Intervention 8 DEVICE

Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RBP) for five minutes

Intervention 8

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biolux Research Holdings, Inc.: lead

Study Sites (1)

Dr. Peter Brawn

Vancouver, B.C, V6A 4G8, Canada

Location

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: Each group in this study includes a different device iteration that is being investigated in parallel.

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: May 13, 2020
• Study Start: January 8, 2020
• Primary Completion: June 24, 2020
• Study Completion: June 24, 2020
• Last Updated: November 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)