An interventional study of BRIUS in Dental Malocclusion, Angle Class II and Angle Class I, sponsored by State University of New York at Buffalo. Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-04.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Treatment
The purpose of this study is to compare the Full Fixed Preadjusted appliances (regular braces) when to the BRIUS system.
This is a randomized controlled trial which aims to identify the effectiveness of alignment in the BRIUS group when compared to the full fixed appliance group.
The secondary aim of the study is to identify any difference in discomfort experienced by the patients when undergoing treatment using the two appliances
The investigators also aim to quantify the extent of tooth movement that is achieved through each appliance within a given time frame
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's enrollment of 13 is below the median of 37 across 242 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →State University of New York at Buffalo is the lead sponsor of 294 studies on the registry; 63 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
BRIUS orthodontic appliance (wire) will be used to treat the patients. BRIUS appliance will be engaged to regular orthodontic brackets intra-orally to initiate orthodontic treatment at the University at Buffalo Orthodontic Clinic.
Device: BRIUS
regular full fixed orthodontic appliance (FFA) appliances will be used to treat patients. These are regular orthodontic brackets with standard orthodontic wires used to treat patients at the University at Buffalo Department of Orthodontics
Device: BRIUS
This is a device that is designed based on movements planned virtually on a computer program. Then all the planned movements are embedded into the wire causing the wire to have the necessary bends to move every tooth into its pre-planned final position. This causes the pre-activated wire to consistently express a low force over a long period of time onto all the teeth. This allows the teeth to move into the final position and treatment progresses towards completion
Overall 3D Movement
absoluate measurement of extent of movement of teeth
Time frame: 18 weeks
Little's Irregularity Index
Little's irregularity index. The index measures the alignment discrepancy in the five contact points of the lower anterior region in millimeteres. The minimum score is zero and the maximum is 10 or above. The greater the score the worse the outcome
Time frame: 18 weeks
Discomfort
Online survey will evaluate discomfort arising from the orthodontic brackets between patients in the two groups. A visual analog scale from 0-10 millimeter will be applied. The greater the score the worse the discomfort level.
Time frame: 18 weeks
| Milestone | BRIUS | Preadjusted Edgewise Full Fixed Appliance |
|---|---|---|
| Started | 7 | 6 |
| Completed | 7 | 6 |
| Not completed | 0 | 0 |
absoluate measurement of extent of movement of teeth
| mm | BRIUS | Preadjusted Edgewise Full Fixed Appliance |
|---|---|---|
| Overall 3D Movement | 1.46 (0.16 to 2) | 1.41 (0.15 to 2.56) |
Little's irregularity index. The index measures the alignment discrepancy in the five contact points of the lower anterior region in millimeteres. The minimum score is zero and the maximum is 10 or above. The greater the score the worse the outcome
| Millimeter | BRIUS | Preadjusted Edgewise Full Fixed Appliance |
|---|---|---|
| Little's Irregularity Index | 5.38 ± 3.04 | 5.04 ± 1.61 |
Online survey will evaluate discomfort arising from the orthodontic brackets between patients in the two groups. A visual analog scale from 0-10 millimeter will be applied. The greater the score the worse the discomfort level.
| units on a scale - millimeter | BRIUS | Preadjusted Edgewise Full Fixed Appliance |
|---|---|---|
| Discomfort | 1.57 (0 to 7) | 38.67 (21 to 59) |
Collected over 18 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BRIUS | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Preadjusted Edgewise Full Fixed Appliance | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | BRIUS | Preadjusted Edgewise Full Fixed Appliance | Total |
|---|---|---|---|
| <=18 years | 7 | 6 | 13 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | BRIUS | Preadjusted Edgewise Full Fixed Appliance | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 5 | 3 | 8 |
| Race and Ethnicity Not Collected(Participants) | BRIUS | Preadjusted Edgewise Full Fixed Appliance | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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State University of New York at Buffalo →