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

Biolux Research

Status: Terminated

Conditions: Orthodontic Tooth Movement

Treatments: Device: Intervention 8; Device: Intervention 3; Device: Intervention 5; Device: Intervention 1; Device: Intervention 7; Device: Intervention 6; Device: Intervention 2; Device: Intervention 4

Study type: Interventional

Funder types: Industry

Identifiers

NCT04386278

RI.2

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 8 patient groups

Intervention 1

Experimental group

Description:

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

Treatment:

Device: Intervention 1

Intervention 2

Experimental group

Description:

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

Treatment:

Device: Intervention 2

Intervention 3

Experimental group

Description:

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

Treatment:

Device: Intervention 3

Intervention 4

Experimental group

Description:

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

Treatment:

Device: Intervention 4

Intervention 5

Experimental group

Description:

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

Treatment:

Device: Intervention 5

Intervention 6

Experimental group

Description:

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

Treatment:

Device: Intervention 6

Intervention 7

Experimental group

Description:

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

Treatment:

Device: Intervention 7

Intervention 8

Experimental group

Description:

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

Treatment:

Device: Intervention 8