BRIUS Vs FFA Efficiency

Study Overview
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Brief Summary
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The purpose of this study is to compare the Full Fixed Preadjusted appliances (regular braces) when to the BRIUS system.

Detailed Description
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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

Official Title
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Alignment and Discomfort Using Non-Sliding Lingual Orthodontic Technique (BRIUS) and Conventional Bracket Systems: A Single-Center Randomized Clinical Trial

Conditions
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Dental Malocclusion, Angle Class II, Angle Class I, Crowding, Tooth

Intervention / Treatment
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* Device: BRIUS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BRIUS<br>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<br>* 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<br>|
| Active Comparator: Preadjusted edgewise full fixed appliance<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement in X, Y, Z planes | absoluate measurement of extent of movement of each tooth in each plane | 18 weeks | 
| Little's irregularity index | Little's irregularity index could potentially be used in epidemiological surveys as a valid method to quantify change in tooth alignment less time-consuming measurement of crowding | 18 weeks | 
| Discomfort | Online survey will evaluate discomfort arising from the orthodontic brackets between patients in the two groups | 18 weeks |