An interventional study of Orthodontic Treatment and OrthoPulse™ in Malocclusion, sponsored by Biolux Research Holdings, Inc.. Completed at 1 site in United States. Open to participants aged 11 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-05-21.
Sponsored by Biolux Research Holdings, Inc. · Not applicable, Interventional, and Treatment
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.
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.
457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.
This study's enrollment of 33 is close to the median of 36 across 372 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Biolux Research Holdings, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Other: Orthodontic Treatment · Device: OrthoPulse™
Subjects assigned to this group receive orthodontic treatment with no OrthoPulse™ treatment.
Other: 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.
Participants carry out daily OrthoPulse™ treatments at home.
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.
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.
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.
| Milestone | BX8RN: Orthodontic Treatment With OrthoPulse™ (Treatment) | BX8RN: Orthodontic Treatment (Control) |
|---|---|---|
| Started | 16 | 17 |
| Completed | 15 | 15 |
| Not completed | 1 | 2 |
Rate of participants orthodontic tooth movement using Little's Index of Irregularity (LII) measured in millimeters per week during alignment.
| millimeters per week | BX8RN: Orthodontic Treatment With OrthoPulse™ (Treatment) | BX8RN: Orthodontic Treatment (Control) |
|---|---|---|
| Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment | 1.09 ± .68 | .39 ± .14 |
The number of significant adverse events reported from time of participant enrolment to study completion for all study participants
| Adverse Events | Fixed Orthodontic Treatment With OrthoPulse™ (Treatment) | Fixed Orthodontic Treatment (Control) |
|---|---|---|
| Safety Evidence of OrthoPulse™ Use | 0 | 0 |
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.
| millimeters | Fixed Orthodontic Treatment With OrthoPulse™ (Treatment) | Fixed Orthodontic Treatment (Control) |
|---|---|---|
| Degree of External Apical Root Resorption (EARR) | 0.02 ± .86 | -0.11 ± .87 |
Collected over Adverse events were collected at all visits from the time of participant enrolment through the study final visit, two (2) years or less.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fixed Orthodontic Treatment With OrthoPulse™ (Treatment) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Fixed Orthodontic Treatment (Control) | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Categorical(Participants) | BX8RN: OrthoPulse™ (Treatment) | BX8RN: Orthodontic Treatment With no OrthoPulse™ (Control) | Total |
|---|---|---|---|
| <=18 years | 10 | 9 | 19 |
| Between 18 and 65 years | 6 | 8 | 14 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | BX8RN: OrthoPulse™ (Treatment) | BX8RN: Orthodontic Treatment With no OrthoPulse™ (Control) | Total |
|---|---|---|---|
| Female | 12 | 6 | 18 |
| Male | 4 | 11 | 15 |
| Region of Enrollment(participants) | BX8RN: OrthoPulse™ (Treatment) | BX8RN: Orthodontic Treatment With no OrthoPulse™ (Control) | Total |
|---|---|---|---|
| United States | 16 | 17 | 33 |
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Biolux Research Holdings, Inc.