Evaluation of a "Flash-free" Adhesive Resin for Orthodontic Bracket Bonding

Not Applicable

Completed

• Conditions: Malocclusion
• Interventions: Device: APC Flash-Free Adhesive Coated Appliance System; Device: APC II Adhesive Coated Appliance System

• Registration Number: NCT02030002
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-10-01
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-08
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-31
• Results First Submitted: 2020-11-19
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-18
• Last Update Submitted: 2020-12-18
• Results First Posted: 2021-01-12
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
APC Flash-Free Adhesive Coated Appliance System	APC Flash-Free Adhesive Coated Appliance System	APC Flash-Free Adhesive Coated Appliance System
APC II Adhesive Coated Appliance System	APC II Adhesive Coated Appliance System	APC II Adhesive Coated Appliance System

Primary Outcome Measures

Name	Time	Method
Bonding Time	At appliance placement, 30 minutes	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.
Bond Survival	1 year post treatment	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.
Amount of Adhesive Remaining on the Tooth Surface After Bracket Debonding	At completion of treatment, 10 minutes.	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.
Time Required for Adhesive Remnant Cleanup	At completion of treatment, 30 minutes.	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States