Clinical trial NCT04347018: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Malocclusion
Angle Class II
Angle Class I
Crowding, Tooth
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 13
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Overall 3D Movement
timeFrame: 18 weeks
measure: Little's Irregularity Index
timeFrame: 18 weeks
measure: Discomfort
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Department of Orthodontics, School of Dental Medicine, SUNY at Buffalo
state: New York
Study officials:
affiliation: Orthodontic resident
name: Mohammed h alzainal, BDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: S.M.R. Peikar, J.S. Wratten Jr, Teeth repositioning systems and methods, Google Patents, 2019.
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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.
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.
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.
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.