CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
UDMA-K18 smooth surface sealantdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03306433
NCT03306433N/ACompleted
CompareCT.gov

Prevention of Enamel Demineralization in Fixed Appliance Orthodontic Patients Using UDMA-K18 Sealant to Prevent Microbial Attachment Compared to a UDMA Control and no Sealant, a Randomized Split Mouth Clinical Trial

University of Colorado, Denver·interventional·Posted Oct 11, 2017·Updated Oct 7, 2021

In Brief

A clinical study evaluating UDMA-K18 smooth surface sealant for Dental Caries. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesUnited States
CollaboratorsUniversity of Colorado School of Dental Medicine

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 11, 2017
Enrollment StartJan 8, 2018
Primary CompletionDec 7, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.7 years ago

Interventions

UDMA-K18 smooth surface sealantdevice

The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.