N/A
N=16
Prevention of Enamel Demineralization by Use of K18-smooth Surface Sealant
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT03306433 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Change in Mineral Density Determined by the Canary Caries Detection System — 23.424; 31.125; 35.563 Canary Number — p=0.0003
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- UDMA-K18 smooth surface sealant (Device)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Dec 2018
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 |
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.
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.
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.