BRIUS Vs FFA Efficiency

NCT04347018 | Completed Results FDA Device

• 1 other identifier: BRvFFA
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Device: BRIUS

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

Device: BRIUS

Interventions

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

BRIUS; Preadjusted edgewise full fixed appliance

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

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

Buffalo, New York, 14214, United States

Location

Related Publications (7)

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

  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.

  PMID: 30472195 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.

  PMID: 21889089 BACKGROUND

• 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.

  PMID: 18929262 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.

  PMID: 20018798 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.

  PMID: 21640885 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.

  PMID: 28339627 RESULT

MeSH Terms

Conditions

Malocclusion; Malocclusion, Angle Class II; Malocclusion, Angle Class I

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Mohammed Al-Zainal
• Organization: University at Buffalo

malzaina@buffalo.edu

7168292845

Study Officials

• Mohammed h alzainal, BDS

  Orthodontic resident

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthodontic Resident

Model Details: 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

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 15, 2020
• Study Start: July 6, 2020
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: October 4, 2024
• Results First Posted: October 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)