Orthodontic Tooth Movement
Conditions
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.
Interventions
DEVICEIntervention 1
Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute
DEVICEIntervention 2
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute
DEVICEIntervention 3
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes
DEVICEIntervention 4
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes
DEVICEIntervention 5
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
DEVICEIntervention 6
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes
DEVICEIntervention 7
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
DEVICEIntervention 8
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RBP) for five minutes
Sponsors
Biolux Research Holdings, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each group in this study includes a different device iteration that is being investigated in parallel.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of orthodontic tooth movement | 36 days (±12 days) from T0 visit | The rate of orthodontic tooth movement during intrusion at 36 days (±12 days) from the T0 Visit (measured in mm per week). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Pain: Questionnaire | 7 Days | 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). |
| Root Resorption | 36 days (±12 days) from T0 visit | Assess tooth resorption by measuring the root length of the first or second bicuspid bilaterally from baseline to T3 |
| Initial Safety of Device | From enrolment to study completion, anticipated six (6) months | Confirmation of safety through collection of adverse events |
Countries
Canada
Outcome results
None listed