BRIUS Vs FFA Efficiency

Dental Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347018
• Other study ID #: BRvFFA
• Status: Completed
• Phase: N/A
• Start date: July 6, 2020
• Est. completion date: June 17, 2022

Study information

• Verified date: September 2022
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 17, 2022
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Department of Orthodontics, School of Dental Medicine, SUNY at Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

Ioshida M, Muñoz 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. — View Citation

S.M.R. Peikar, J.S. Wratten Jr, Teeth repositioning systems and methods, Google Patents, 2019.

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.2008.04.01 — View Citation

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. — View Citation

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.2009.0 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement in X, Y, Z planes	absoluate measurement of extent of movement of each tooth in each plane	18 weeks
Primary	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
Primary	Discomfort	Online survey will evaluate discomfort arising from the orthodontic brackets between patients in the two groups	18 weeks

External Links

•   Link with photos of before and after cases showing how the device is used regularly by orthodontists around the world to treat patients
•   manufacturer website for intervention device with more information relevant to patients
•   Video from the manufacturer showing a 3D illustration of how the device works