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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT02030002
First received: December 3, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Malocclusion
Device: APC Flash-Free Adhesive Coated Appliance System
Device: APC II Adhesive Coated Appliance System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Bonding time [ Time Frame: At appliance placement, 30 minutes ] [ Designated as safety issue: No ]
    It is hypothesized that there is no significant difference in bonding time between brackets bonded with the "flash-free" adhesive and those bonded with a conventional adhesive.

  • Bond survival [ Time Frame: Over the course of a 2-year treatment at 4-week intervals. ] [ Designated as safety issue: No ]
    It is hypothesized that there is no significant difference in bond failure rate between brackets bonded with the "flash-free" adhesive and those bonded with a conventional adhesive.

  • Amount of adhesive remaining on the tooth surface after bracket debonding [ Time Frame: At completion of treatment, 10 minutes. ] [ Designated as safety issue: No ]
    It is hypothesized that there is no significant difference in the amount of adhesive remaining on the tooth surface after bracket debonding between brackets bonded with the "flash-free" adhesive and those bonded with a conventional adhesive.

  • Time required for adhesive remnant cleanup [ Time Frame: At completion of treatment, 30 minutes. ] [ Designated as safety issue: No ]
    It is hypothesized that there is no significant difference in time required for adhesive remnant cleanup after debonding between brackets bonded with the "flash-free" adhesive and those bonded with a conventional adhesive.


Estimated Enrollment: 45
Study Start Date: October 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APC Flash-Free Adhesive Coated Appliance System
APC Flash-Free Adhesive Coated Appliance System
Device: APC Flash-Free Adhesive Coated Appliance System
Active Comparator: APC II Adhesive Coated Appliance System
APC II Adhesive Coated Appliance System
Device: APC II Adhesive Coated Appliance System

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.

  Eligibility

Ages Eligible for Study:   10 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02030002

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Thorsten Gruenheid, DDS, PhD    612-625-3903      
Principal Investigator: Thorsten Gruenheid, DDS, PhD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
3M
Investigators
Principal Investigator: Thorsten Gruenheid, DDS, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02030002     History of Changes
Other Study ID Numbers: 1/2013
Study First Received: December 3, 2013
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Malocclusion
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on October 30, 2014