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

Biolux Research Holdings, Inc.56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Orthodontic Tooth Movement

Interventions

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

Intervention 2DEVICE

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

Intervention 3DEVICE

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

Intervention 4DEVICE

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

Intervention 5DEVICE

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

Intervention 6DEVICE

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

Intervention 7DEVICE

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

Intervention 8DEVICE

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

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dr. Peter Brawn

Vancouver, B.C, Canada

Outcomes

Primary Outcomes

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).

Time frame: 36 days (±12 days) from T0 visit

Secondary Outcomes

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).

Time frame: 7 Days

Root Resorption

Assess tooth resorption by measuring the root length of the first or second bicuspid bilaterally from baseline to T3

Time frame: 36 days (±12 days) from T0 visit

Initial Safety of Device

Confirmation of safety through collection of adverse events

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

Data from ClinicalTrials.gov

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