N/A Completed N=16 Randomized Quadruple-blind Prevention

Prevention of Enamel Demineralization by Use of K18-smooth Surface Sealant

Source: ClinicalTrials.gov NCT03306433 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcomePrimary: Change in Mineral Density Determined by the Canary Caries Detection System — 23.424; 31.125; 35.563 Canary Number — p=0.0003

Summary

This study will evaluate effectiveness of a urethane dimethacrylate (UDMA)-quaternary ammonium methacrylate (K18) resin (UDMA-K18) smooth surface sealant to prevent biofilm attachment to tooth surfaces thereby eliminating the possibility for the tooth to be demineralized. The hypothesis is that UDMA-K18 containing smooth surface sealant will be more effective at reducing enamel demineralization than the UDMA control or no treatment.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mineral Density Determined by the Canary Caries Detection System	23.424; 31.125; 35.563	0.0003 sig
SECONDARY White Spot Lesion (WSL) Index	0; 2; 2	0.0033 sig

Eligibility Criteria

Inclusion Criteria

Orthodontic patients at the Department of Orthodontics Clinic, School of Dental Medicine, University of Colorado who agree to consent to this study.
Orthodontic treatment plans that include fixed appliances from the second premolar to second premolar in both arches.
Orthodontic treatment plans that include extractions of at least 3 bicuspids at about 1 month after bracket placement.
The patient has adequate oral hygiene

Exclusion Criteria

Evidence of decalcification or restorations on any of the premolars planned for extraction prior to orthodontic treatment,
Pregnant women (self reported)
Any condition that contraindicates orthodontic treatment,
Not willing to consent to the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03306433). 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. Informational only — not medical advice.