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

University of Minnesota (UMN)

Status: Completed

Conditions: Malocclusion

Treatments: Device: APC Flash-Free Adhesive Coated Appliance System; Device: APC II Adhesive Coated Appliance System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02030002

1/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 10 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

APC Flash-Free Adhesive Coated Appliance System

Experimental group

Description:

APC Flash-Free Adhesive Coated Appliance System

Treatment:

Device: APC Flash-Free Adhesive Coated Appliance System

APC II Adhesive Coated Appliance System

Active Comparator group

Description:

APC II Adhesive Coated Appliance System

Treatment:

Device: APC II Adhesive Coated Appliance System