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

Malocclusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030002
• Other study ID #: 1/2013
• Status: Completed
• Phase: N/A
• Start date: October 1, 2013
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 31, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• APC Flash-Free Adhesive Coated Appliance System
APC Flash-Free Adhesive Coated Appliance System
• APC II Adhesive Coated Appliance System
APC II Adhesive Coated Appliance System

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bonding Time	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.	At appliance placement, 30 minutes
Primary	Bond Survival	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.	1 year post treatment
Primary	Amount of Adhesive Remaining on the Tooth Surface After Bracket Debonding	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.	At completion of treatment, 10 minutes.
Primary	Time Required for Adhesive Remnant Cleanup	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.	At completion of treatment, 30 minutes.