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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRIUS | Experimental | 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. |
|
| Preadjusted edgewise full fixed appliance | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRIUS | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall 3D Movement | absoluate measurement of extent of movement of teeth | 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 | 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. | 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed h alzainal, BDS | Orthodontic resident | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthodontics, School of Dental Medicine, SUNY at Buffalo | Buffalo | New York | 14214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | S.M.R. Peikar, J.S. Wratten Jr, Teeth repositioning systems and methods, Google Patents, 2019. | ||
| 30472195 | Background | Ioshida M, Munoz BA, Rios H, Cevidanes L, Aristizabal JF, Rey D, Kim-Berman H, Yatabe M, Benavides E, Alvarez MA, Volk S, Ruellas AC. Accuracy and reliability of mandibular digital model registration with use of the mucogingival junction as the reference. Oral Surg Oral Med Oral Pathol Oral Radiol. 2019 Apr;127(4):351-360. doi: 10.1016/j.oooo.2018.10.003. Epub 2018 Oct 16. | |
| 21889089 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall 3D Movement | absoluate measurement of extent of movement of teeth | Posted | Median | Inter-Quartile Range | mm | 18 weeks |
|
18 weeks
None of the participants had any risk factors that could cause serious adverse events or mortality
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohammed Al-Zainal | University at Buffalo | 7168292845 | malzaina@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2022 | Nov 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D008312 | Malocclusion, Angle Class II |
| D008311 | Malocclusion, Angle Class I |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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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
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|
| Background |
| Grauer D, Proffit WR. Accuracy in tooth positioning with a fully customized lingual orthodontic appliance. Am J Orthod Dentofacial Orthop. 2011 Sep;140(3):433-43. doi: 10.1016/j.ajodo.2011.01.020. |
| 18929262 | Result | Scott P, DiBiase AT, Sherriff M, Cobourne MT. Alignment efficiency of Damon3 self-ligating and conventional orthodontic bracket systems: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2008 Oct;134(4):470.e1-8. doi: 10.1016/j.ajodo.2008.04.018. |
| 20018798 | Result | Wu AK, McGrath C, Wong RW, Wiechmann D, Rabie AB. A comparison of pain experienced by patients treated with labial and lingual orthodontic appliances. Eur J Orthod. 2010 Aug;32(4):403-7. doi: 10.1093/ejo/cjp117. Epub 2009 Dec 16. |
| 21640885 | Result | Wu A, McGrath C, Wong RW, Wiechmann D, Rabie AB. Comparison of oral impacts experienced by patients treated with labial or customized lingual fixed orthodontic appliances. Am J Orthod Dentofacial Orthop. 2011 Jun;139(6):784-90. doi: 10.1016/j.ajodo.2009.07.027. |
| 28339627 | Result | Talaat S, Kaboudan A, Bourauel C, Ragy N, Kula K, Ghoneima A. Validity and reliability of three-dimensional palatal superimposition of digital dental models. Eur J Orthod. 2017 Aug 1;39(4):365-370. doi: 10.1093/ejo/cjx008. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 |
| 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 |
|
|
| 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 | Posted | Mean | Standard Deviation | Millimeter | 18 weeks |
|
|
|
| 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. | Posted | Mean | Inter-Quartile Range | units on a scale - millimeter | 18 weeks |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 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 | 0 | 6 | 0 | 6 | 0 | 6 |
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