BRIUS Vs FFA Efficiency

Not Applicable

Completed

• Conditions: Dental Malocclusion; Angle Class II; Angle Class I; Crowding, Tooth
• Interventions: Device: BRIUS

• Registration Number: NCT04347018
• Lead Sponsor: State University of New York at Buffalo

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

Study Timeline

• Study First Submitted: 2020-04-12
• Study First Submitted QC: 2020-04-12
• Study First Posted: 2020-04-15
• Study Start: 2020-07-06
• Primary Completion: 2022-06-17
• Study Completion: 2022-06-17
• Results First Submitted: 2023-11-14
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Results First Posted: 2024-10-04
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preadjusted edgewise full fixed appliance	BRIUS	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
BRIUS	BRIUS	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.

Primary Outcome Measures

Name	Time	Method
Overall 3D Movement	18 weeks	absoluate measurement of extent of movement of teeth
Little's Irregularity Index	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
Discomfort	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.

Trial Locations

Locations (1)

Department of Orthodontics, School of Dental Medicine, SUNY at Buffalo; 🇺🇸 Buffalo, New York, United States