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Completed

NCT Number: NCT02030002

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

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.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

10 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APC Flash-Free Adhesive Coated Appliance System

Device

APC Flash-Free Adhesive Coated Appliance System

APC II Adhesive Coated Appliance System

Device

APC II Adhesive Coated Appliance System

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • 3M

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jan 8, 2014
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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