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

NCT03306433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-10-07

Study results available
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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.

Conditions

  • Dental Caries

Interventions

DEVICE

UDMA-K18 smooth surface sealant

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

Sponsors & Collaborators

  • University of Colorado School of Dental Medicine

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Clifton Carey, PhD · Professor, Dir Translational Research, University of Colorado, School of Dental Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2018-12-07
Completion
2018-12-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03306433 on ClinicalTrials.gov