Clinical trial NCT02030002: Evaluation of a "Flash-free" Adhesive Resin for Orthodontic Bracket Bonding
Official title: Use of a "Flash-free" Adhesive Resin for Orthodontic Bracket Bonding: a Clinical Study of Bonding Time, Bond Survival, and Adhesive Remnant Cleanup
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2014-01-08
Enrollment: 49
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Split-mouth
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare bonding time, bond survival, amount of adhesive remaining on the tooth surface after bracket debonding, and time required for adhesive remnant cleanup between a new "flash-free" and a conventional adhesive resin for orthodontic bracket bonding.

Detailed description: Patients presenting for comprehensive orthodontic treatment with fixed appliances at the University of Minnesota, who are willing to participate, will be included in the initial study. Selection criteria will include full permanent dentition through the first molars, teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide, and no previous orthodontic treatment with fixed appliances. The patients will have their maxillary incisors, canines, and premolars bonded with ceramic orthodontic brackets pre-coated with a "flash-free" adhesive resin (Clarity Advanced Brackets APC flash-free, 3M Unitek, Monrovia, CA, USA) on one side and a conventional adhesive resin (Clarity Advanced Brackets APC II, 3M Unitek) on the other side. The side allocation and order of bonding will be randomized for each patient.

Eligibility criteria: Inclusion Criteria:

* Full permanent dentition including incisors, canines, premolars, and first molars
* Teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide
* No previous orthodontic treatment with fixed appliances

Exclusion Criteria:

* Mental/emotional/developmental disability
* Cleft lip and/or palate, craniofacial anomaly, or syndrome
* Obvious oral hygiene issues such as excessive plaque accumulation, gingivitis, and/or pre-existing white spot lesions
* Prosthodontic or restored substrate extending on the labial surface of maxillary teeth
* Known allergies to any acrylates contained in the study materials

Primary outcomes:
measure: Bonding Time
timeFrame: At appliance placement, 30 minutes
measure: Bond Survival
timeFrame: 1 year post treatment
measure: Amount of Adhesive Remaining on the Tooth Surface After Bracket Debonding
timeFrame: At completion of treatment, 10 minutes.
measure: Time Required for Adhesive Remnant Cleanup
timeFrame: At completion of treatment, 30 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Thorsten Gruenheid, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grunheid T, Larson BE. Comparative assessment of bonding time and 1-year bracket survival using flash-free and conventional adhesives for orthodontic bracket bonding: A split-mouth randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Nov;154(5):621-628. doi: 10.1016/j.ajodo.2018.05.012.
citation: Grunheid T, Larson BE. A comparative assessment of bracket survival and adhesive removal time using flash-free or conventional adhesive for orthodontic bracket bonding: A split-mouth randomized controlled clinical trial. Angle Orthod. 2019 Mar;89(2):299-305. doi: 10.2319/030918-195.1. Epub 2018 Sep 19.