Angle Class I, Angle Class II, Crowding, Tooth, Dental Malocclusion
Conditions
Brief summary
The purpose of this study is to compare the Full Fixed Preadjusted appliances (regular braces) when to the BRIUS system.
Detailed description
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
Interventions
DEVICEBRIUS
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
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
2 groups will receive treatment and be observed over the course of the alignment phase of their orthodontic treatment. Regular photographic records will be taken during appointments and the data will be analysed after the 18 week period is completed for all patients involved in the study
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* 10 to 18 years old * Angle Class I and Cl II (up to half cusp) molar and canine relationship. * Fully erupted permanent dentition (excluding third molars). * Crowding of 7 mm or less. * Must be able to maintain good oral hygiene assessed by the orthodontist during their visits.
Exclusion criteria
* Previous history of orthodontic treatment or orthognathic surgery * Subjects who require extractions or orthognathic surgery * Multiple missed appointments * Deteriorating oral hygiene and craniofacial syndromes or disorders * Severe gag reflex resulting from the use of intra-oral scanners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall 3D Movement | 18 weeks | absoluate measurement of extent of movement of teeth |
| Little's Irregularity Index | 18 weeks | 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 |
| Discomfort | 18 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BRIUS 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.
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 | 7 |
| Preadjusted Edgewise Full Fixed Appliance 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
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 | 6 |
| Total | 13 |
Baseline characteristics
| Characteristic | BRIUS | Preadjusted Edgewise Full Fixed Appliance | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 7 Participants | 6 Participants | 13 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 |
| other Total, other adverse events | 0 / 7 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BRIUS | Discomfort | 1.57 units on a scale - millimeter |
| Preadjusted Edgewise Full Fixed Appliance | Discomfort | 38.67 units on a scale - millimeter |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BRIUS | Little's Irregularity Index | 5.38 Millimeter | Standard Deviation 3.04 |
| Preadjusted Edgewise Full Fixed Appliance | Little's Irregularity Index | 5.04 Millimeter | Standard Deviation 1.61 |
Primary
Overall 3D Movement
absoluate measurement of extent of movement of teeth
Time frame: 18 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BRIUS | Overall 3D Movement | 1.46 mm |
| Preadjusted Edgewise Full Fixed Appliance | Overall 3D Movement | 1.41 mm |