Overview

This trial is active, not recruiting.

Condition malocclusion
Treatments apc flash-free adhesive coated appliance system, apc ii adhesive coated appliance system
Sponsor University of Minnesota - Clinical and Translational Science Institute
Collaborator 3M
Start date October 2013
End date October 2016
Trial size 45 participants
Trial identifier NCT02030002, 1/2013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
APC Flash-Free Adhesive Coated Appliance System
apc flash-free adhesive coated appliance system
APC Flash-Free Adhesive Coated Appliance System
(Active Comparator)
APC II Adhesive Coated Appliance System
apc ii adhesive coated appliance system
APC II Adhesive Coated Appliance System

Primary Outcomes

Measure
Bonding time
time frame: At appliance placement, 30 minutes
Bond survival
time frame: Over the course of a 2-year treatment at 4-week intervals.
Amount of adhesive remaining on the tooth surface after bracket debonding
time frame: At completion of treatment, 10 minutes.
Time required for adhesive remnant cleanup
time frame: At completion of treatment, 30 minutes.

Eligibility Criteria

Male or female participants from 10 years up to 60 years old.

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

Additional Information

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
Principal investigator Thorsten Gruenheid, DDS, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.