Adults 12 to 89, any sex, with Dental Caries. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Mineral Density Determined by the Canary Caries Detection SystemPrimary· Visit Window: 3-4 weeks.
The mineral density immediately below the surface of the tooth will lower if left unprotected to some extent.
Group
Value
95% CI
UDMA-K18
23.424
± 3.288
UDMA-control
31.125
± 4.275
Adhesive Control
35.563
± 7.378
White Spot Lesion (WSL) IndexSecondary· Visit Window: 3-4 weeks.
The WSL Index is from 0 (no lesion) to 4 (severe lesion)
Group
Value
95% CI
UDMA-K18
0
0 – 2
UDMA-control
2
0 – 2
Adhesive Control
2
1 – 3
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
Last refreshed: 7 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03306433.