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BRIUS Vs FFA Efficiency

Primary Purpose

Dental Malocclusion, Angle Class II, Angle Class I

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BRIUS

About this trial

This is an interventional treatment trial for Dental Malocclusion

Eligibility Criteria

10 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Orthodontics, School of Dental Medicine, SUNY at Buffalo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BRIUS

Preadjusted edgewise full fixed appliance

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Movement in X, Y, Z planes

absoluate measurement of extent of movement of each tooth in each plane

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

Discomfort

Online survey will evaluate discomfort arising from the orthodontic brackets between patients in the two groups

Secondary Outcome Measures

Full Information

NCT ID

NCT04347018

First Posted

April 12, 2020

Last Updated

September 2, 2022

Sponsor

State University of New York at Buffalo

1. Study Identification

Unique Protocol Identification Number

NCT04347018

Brief Title

BRIUS Vs FFA Efficiency

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

July 6, 2020 (Actual)

Primary Completion Date

June 17, 2022 (Actual)

Study Completion Date

June 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

State University of New York at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Outcomes Assessor

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BRIUS

Arm Type

Experimental

Arm Description

Arm Title

Preadjusted edgewise full fixed appliance

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

BRIUS

Intervention Description

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 Outcome Measure Information:

Title

Movement in X, Y, Z planes

Description

absoluate measurement of extent of movement of each tooth in each plane

Time Frame

18 weeks

Title

Little's irregularity index

Description

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

Time Frame

18 weeks

Title

Discomfort

Description

Online survey will evaluate discomfort arising from the orthodontic brackets between patients in the two groups

Time Frame

18 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammed h alzainal, BDS

Organizational Affiliation

Orthodontic resident

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Orthodontics, School of Dental Medicine, SUNY at Buffalo

City

Buffalo

State/Province

New York

ZIP/Postal Code

14214

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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

Results Reference

background

PubMed Identifier

30472195

Citation

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.

Results Reference

background

PubMed Identifier

21889089

Citation

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.

Results Reference

background

PubMed Identifier

18929262

Citation

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.

Results Reference

result

PubMed Identifier

20018798

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.

Results Reference

result

PubMed Identifier

21640885

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.2009.07.027.

Results Reference

result

PubMed Identifier

28339627

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.

Results Reference

result

Links:

URL

http://www.brius.com

Description

manufacturer website for intervention device with more information relevant to patients

URL

https://youtu.be/sGLxSLxrl4U

Description

Video from the manufacturer showing a 3D illustration of how the device works

URL

https://brius.com/orthodontists/

Description

Link with photos of before and after cases showing how the device is used regularly by orthodontists around the world to treat patients

Learn more about this trial

BRIUS Vs FFA Efficiency

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