Evaluation of a "Flash-free" Adhesive Resin for Orthodontic Bracket Bonding
This trial is active, not recruiting.
|Treatments||apc flash-free adhesive coated appliance system, apc ii adhesive coated appliance system|
|Sponsor||University of Minnesota - Clinical and Translational Science Institute|
|Start date||October 2013|
|End date||October 2016|
|Trial size||45 participants|
|Trial identifier||NCT02030002, 1/2013|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
time frame: At appliance placement, 30 minutes
time frame: Over the course of a 2-year treatment at 4-week intervals.
Amount of adhesive remaining on the tooth surface after bracket debonding
time frame: At completion of treatment, 10 minutes.
Time required for adhesive remnant cleanup
time frame: At completion of treatment, 30 minutes.
Male or female participants from 10 years up to 60 years old.
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
|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|
|Principal investigator||Thorsten Gruenheid, DDS, PhD|
|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.|
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