Skip to main content
OpenTrials
Completed

NCT Number: NCT04347018

BRIUS Vs FFA Efficiency

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Buffalo, New York, 14214, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Overall 3D Movement

    Time frame: 18 weeks

    absoluate measurement of extent of movement of teeth

  2. Little's Irregularity Index

    Time frame: 18 weeks

    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

  3. Discomfort

    Time frame: 18 weeks

    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.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 15, 2020
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.