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

Primary Purpose

Malocclusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
APC Flash-Free Adhesive Coated Appliance System
APC II Adhesive Coated Appliance System
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion

Eligibility Criteria

10 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

APC Flash-Free Adhesive Coated Appliance System

APC II Adhesive Coated Appliance System

Arm Description

APC Flash-Free Adhesive Coated Appliance System

APC II Adhesive Coated Appliance System

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 3, 2013
Last Updated
December 18, 2020
Sponsor
University of Minnesota
Collaborators
3M
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1. Study Identification

Unique Protocol Identification Number
NCT02030002
Brief Title
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2013 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
3M

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Split-mouth
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APC Flash-Free Adhesive Coated Appliance System
Arm Type
Experimental
Arm Description
APC Flash-Free Adhesive Coated Appliance System
Arm Title
APC II Adhesive Coated Appliance System
Arm Type
Active Comparator
Arm Description
APC II Adhesive Coated Appliance System
Intervention Type
Device
Intervention Name(s)
APC Flash-Free Adhesive Coated Appliance System
Intervention Description
APC Flash-Free Adhesive Coated Appliance System
Intervention Type
Device
Intervention Name(s)
APC II Adhesive Coated Appliance System
Intervention Description
APC II Adhesive Coated Appliance System
Primary Outcome Measure Information:
Title
Bonding Time
Description
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.
Time Frame
At appliance placement, 30 minutes
Title
Bond Survival
Description
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.
Time Frame
1 year post treatment
Title
Amount of Adhesive Remaining on the Tooth Surface After Bracket Debonding
Description
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 Frame
At completion of treatment, 10 minutes.
Title
Time Required for Adhesive Remnant Cleanup
Description
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.
Time Frame
At completion of treatment, 30 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thorsten Gruenheid, DDS, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30384932
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.
Results Reference
derived
PubMed Identifier
30230375
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.
Results Reference
derived

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

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