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

NCT ID: NCT02030002

Last Updated: 2021-01-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Split-mouth
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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APC Flash-Free Adhesive Coated Appliance System

APC Flash-Free Adhesive Coated Appliance System

Group Type EXPERIMENTAL

APC Flash-Free Adhesive Coated Appliance System

Intervention Type DEVICE

APC Flash-Free Adhesive Coated Appliance System

APC II Adhesive Coated Appliance System

APC II Adhesive Coated Appliance System

Group Type ACTIVE_COMPARATOR

APC II Adhesive Coated Appliance System

Intervention Type DEVICE

APC II Adhesive Coated Appliance System

Interventions

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APC Flash-Free Adhesive Coated Appliance System

APC Flash-Free Adhesive Coated Appliance System

Intervention Type DEVICE

APC II Adhesive Coated Appliance System

APC II Adhesive Coated Appliance System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thorsten Gruenheid, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30384932 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30230375 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1/2013

Identifier Type: -

Identifier Source: org_study_id

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