NCT02030002

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Malocclusion

Interventions

Type	Name	Description
DEVICE	APC Flash-Free Adhesive Coated Appliance System	APC Flash-Free Adhesive Coated Appliance System
DEVICE	APC II Adhesive Coated Appliance System	APC II Adhesive Coated Appliance System

Timeline

• Start date: 2013-10-01
• Primary completion: 2019-12-01
• Completion: 2019-12-31
• First posted: 2014-01-08
• Last updated: 2021-01-12
• Results posted: 2021-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study