Malocclusion
Conditions
Keywords
Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™
Brief summary
This open label study is designed to evaluate the ability of OrthoPulse™ to safely and effectively increase the rate of orthodontic tooth movement with fixed appliances.
Detailed description
The primary aim of this study is to determine if daily OrthoPulse™ use affects the rate of orthodontic tooth movement during alignment with fixed appliances in the mandibular arch. The secondary aim of this study is to determine whether patients treated with OrthoPulse demonstrate root resorption beyond what is commonly expected during orthodontic treatment. The study also aims to collect confirmatory evidence on the safety of the device.
Interventions
OTHEROrthodontic Treatment
Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
DEVICEOrthoPulse™
Participants carry out daily OrthoPulse™ treatments at home.
Sponsors
Biolux Research Holdings, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Eligible and scheduled for full mouth fixed orthodontic treatment * Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth * Class I or Class II by 1/2 cusp or less * Non-extraction in both arches * Age 11- 60 * Good oral hygiene * Non-smokerInclud
Exclusion criteria
* Pregnant females * Patient is currently enrolled in another clinical study * Patient decided on Invisalign® rather than braces * Periodontally involved teeth * Use of bisphosphonates (osteoporosis drugs) during the study * Patient plans to move over the treatment period * Spaces between anterior teeth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment | Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case. | Rate of participants orthodontic tooth movement using Little's Index of Irregularity (LII) measured in millimeters per week during alignment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Evidence of OrthoPulse™ Use | Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case. | The number of significant adverse events reported from time of participant enrolment to study completion for all study participants |
| Degree of External Apical Root Resorption (EARR) | Assessed at six (6) months or later after starting treatment, up to two (2) years. | The amount of EARR experienced as assessed at six (6) months or later after starting treatment. External Apical Root Resorption can result from orthodontic tooth movement. External apical root resorption is the shortening of the root and affects root surface(s), which can result in loss of tooth structure. External apical root resorption is being determined in this study by comparing root lengths from initial to six (6) months or later after starting treatment. The measurements are taken from the crown to the root apex in millimeters. A positive number under the measure of dispersion signifies root resorption. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BX8RN: OrthoPulse™ (Treatment) Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home. | 16 |
| BX8RN: Orthodontic Treatment With no OrthoPulse™ (Control) Subjects assigned to this group receive orthodontic treatment with no daily OrthoPulse™ treatments.
Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office. | 17 |
| Total | 33 |
Baseline characteristics
| Characteristic | BX8RN: OrthoPulse™ (Treatment) | BX8RN: Orthodontic Treatment With no OrthoPulse™ (Control) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 9 Participants | 19 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 8 Participants | 14 Participants |
| Region of Enrollment United States | 16 participants | 17 participants | 33 participants |
| Sex: Female, Male Female | 12 Participants | 6 Participants | 18 Participants |
| Sex: Female, Male Male | 4 Participants | 11 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 17 |
| other Total, other adverse events | 0 / 16 | 0 / 17 |
| serious Total, serious adverse events | 0 / 16 | 0 / 17 |
Outcome results
Primary
Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment
Rate of participants orthodontic tooth movement using Little's Index of Irregularity (LII) measured in millimeters per week during alignment.
Time frame: Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BX8RN: Orthodontic Treatment With OrthoPulse™ (Treatment) | Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment | 1.09 millimeters per week | Standard Deviation 0.68 |
| BX8RN: Orthodontic Treatment (Control) | Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment | .39 millimeters per week | Standard Deviation 0.14 |
Secondary
Degree of External Apical Root Resorption (EARR)
The amount of EARR experienced as assessed at six (6) months or later after starting treatment. External Apical Root Resorption can result from orthodontic tooth movement. External apical root resorption is the shortening of the root and affects root surface(s), which can result in loss of tooth structure. External apical root resorption is being determined in this study by comparing root lengths from initial to six (6) months or later after starting treatment. The measurements are taken from the crown to the root apex in millimeters. A positive number under the measure of dispersion signifies root resorption.
Time frame: Assessed at six (6) months or later after starting treatment, up to two (2) years.
Population: The overall number of participants is not consistent with the number of participants analyzed in this arm because the panoramic radiographs required to analyze the EARR were not available for the remaining 11 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BX8RN: Orthodontic Treatment With OrthoPulse™ (Treatment) | Degree of External Apical Root Resorption (EARR) | 0.02 millimeters | Standard Deviation 0.86 |
| BX8RN: Orthodontic Treatment (Control) | Degree of External Apical Root Resorption (EARR) | -0.11 millimeters | Standard Deviation 0.87 |
Secondary
Safety Evidence of OrthoPulse™ Use
The number of significant adverse events reported from time of participant enrolment to study completion for all study participants
Time frame: Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BX8RN: Orthodontic Treatment With OrthoPulse™ (Treatment) | Safety Evidence of OrthoPulse™ Use | 0 Adverse Events |
| BX8RN: Orthodontic Treatment (Control) | Safety Evidence of OrthoPulse™ Use | 0 Adverse Events |