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

December 18, 2020 updated by: University of Minnesota

Use of a "Flash-free" Adhesive Resin for Orthodontic Bracket Bonding: a Clinical Study of Bonding Time, Bond Survival, and Adhesive Remnant Cleanup

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APC Flash-Free Adhesive Coated Appliance System
Device: APC Flash-Free Adhesive Coated Appliance System
APC Flash-Free Adhesive Coated Appliance System
Active Comparator: APC II Adhesive Coated Appliance System
Device: APC II Adhesive Coated Appliance System
APC II Adhesive Coated Appliance System

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

3M

Investigators

  • Principal Investigator: Thorsten Gruenheid, DDS, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

January 7, 2014

First Posted (Estimate)

January 8, 2014

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

December 18, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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