N/A N=49 Randomized Treatment

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

Malocclusion

Bottom Line

View on ClinicalTrials.gov: NCT02030002 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: Bonding Time — 42.5; 67.7 seconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: APC Flash-Free Adhesive Coated Appliance System (Device); APC II Adhesive Coated Appliance System (Device)
Age: Pediatric, Adult · 10+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Bonding Time	42.5; 67.7	—
PRIMARY Bond Survival	8; 2	—
PRIMARY Amount of Adhesive Remaining on the Tooth Surface After Bracket Debonding	2.53; 2.29	—
PRIMARY Time Required for Adhesive Remnant Cleanup	167.3; 215.1	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02030002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.