N/A
N=13
BRIUS Vs FFA Efficiency
Dental Malocclusion · Angle Class II · Angle Class I · Crowding, Tooth
Bottom Line
View on ClinicalTrials.gov: NCT04347018 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Overall 3D Movement — 1.46; 1.41 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BRIUS (Device)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall 3D Movement |
1.46; 1.41 | — |
| PRIMARY Little's Irregularity Index |
5.38; 5.04 | — |
| PRIMARY Discomfort |
1.57; 38.67 | — |
Summary
The purpose of this study is to compare the Full Fixed Preadjusted appliances (regular braces) when to the BRIUS system.
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
Data sourced from ClinicalTrials.gov (NCT04347018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.