Evaluation of a "Flash-free" Adhesive Resin for Orthodontic Bracket Bonding
Use of a "Flash-free" Adhesive Resin for Orthodontic Bracket Bonding: a Clinical Study of Bonding Time, Bond Survival, and Adhesive Remnant Cleanup
1 other identifier
interventional
49
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 3, 2013
CompletedFirst Posted
Study publicly available on registry
January 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedResults Posted
Study results publicly available
January 12, 2021
CompletedJanuary 12, 2021
December 1, 2020
6.2 years
December 3, 2013
November 19, 2020
December 18, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Bonding Time
The time taken to bond each tooth was timed to the nearest second using a digital stopwatch. Timing was started after enamel surface preparation and stopped before light curing. Outcome reported in seconds.
At appliance placement, 30 minutes
Bond Survival
Bond failure (yes or no) was recorded at standardized appointments at intervals of 4 weeks. Outcome is reported as the cumulative number of failed bracket bonds across all participants at 1 year post-treatment.
1 year post treatment
Amount of Adhesive Remaining on the Tooth Surface After Bracket Debonding
In case of a bond failure, the adhesive remnant index (ARI) was scored. The ARI is a point-based system ranking: 0, no adhesive left on the tooth; 1, less than half of the adhesive left on the tooth; 2, more than half of the adhesive left on the tooth; and 3, all adhesive left on the tooth.
At completion of treatment, 10 minutes.
Time Required for Adhesive Remnant Cleanup
If adhesive remained after bracket de-bonding, then the time required to remove the remnant adhesive was measured using a digital stop-watch. Outcome is reported in seconds.
At completion of treatment, 30 minutes.
Study Arms (2)
APC Flash-Free Adhesive Coated Appliance System
EXPERIMENTALAPC Flash-Free Adhesive Coated Appliance System
APC II Adhesive Coated Appliance System
ACTIVE COMPARATORAPC II Adhesive Coated Appliance System
Interventions
APC Flash-Free Adhesive Coated Appliance System
APC II Adhesive Coated Appliance System
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- 3Mcollaborator
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Related Publications (2)
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.
PMID: 30384932DERIVEDGrunheid 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.
PMID: 30230375DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thorsten Gruenheid
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Thorsten Gruenheid, DDS, PhD
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2013
First Posted
January 8, 2014
Study Start
October 1, 2013
Primary Completion
December 1, 2019
Study Completion
December 31, 2019
Last Updated
January 12, 2021
Results First Posted
January 12, 2021
Record last verified: 2020-12