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NCT02424097 · ClinicalTrials.gov registry record · Phase 4
MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study
A Phase 4 study of Dental Caries and Dental White Spots, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT02424097: Completed Phase 4 study of Dental Caries and Dental White Spots, sponsored by University of California, San Francisco.
NCT02424097 is a Phase 4 study of Dental Caries and Dental White Spots that has completed, run by University of California, San Francisco. The registered enrollment target is 40 participants, below the 721-participant average among 30 other Dental Caries trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02424097, a Phase 4 study of Dental Caries and Dental White Spots, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this clinical study is to evaluate the efficacy of multiple applications of MI Varnish in combination with MI Paste Plus in caries protection and remineralization in comparison to the use of a control (Crest 1,100ppm Fluoride tooth paste, Fluoride rinse recommendation) in orthodontic patients in a randomized, single blind, prospective, controlled clinical trial over 12 months. The effect will be measured by white spot lesion regression and prevention as lesion count. Lesions will be scored using the Enamel Decalcification Index (EDI) area evaluation scheme (primary outcome), International Caries Detection and Assessment System (ICDAS), the caries lesion activity criteria (Nyvad criteria; Bente Nyvad, Scandinavian Researcher), and Quantitative Light Fluorescence (QLF, Inspektor Pro, Netherlands)/SOPROLIFE (SOPROLIFE fluorescence camera system, Acteon, France) evaluation in maxillary and mandibular anterior teeth with orthodontic brackets in treatment and control groups.
Primary Outcome
The area evaluation scheme of the Enamel Decalcification Index (EDI) divides the buccal surface of each tooth into 4 quadrants and then registers the possible existence of a white spot lesion (decalcification) in each of these 4 quadrants. For each quadrant the lesion can be scaled as: 0 = no decalcification, 1 = decalcification covering \<50% of the area, 2 = decalcification covering \> 50% of the area, 3 = decalcifications covering 100% of the area or severe decalcification with cavitation. Th
Conditions Studied
Interventions
- DRUG CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste
- DRUG 1,100pm F-toothpaste and 0.5%NaF rinse
Study Locations (1)
California
- UCSF School of Dentistry - Dental Offices in Bay Area - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-10 |
| Phase | Phase 4 |
What the finished NCT02424097 record still lists
NCT02424097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 721-participant average among 30 other Dental Caries trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Dental Caries appearing as the primary indexed condition, and to 2 interventions - of which CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste is the first listed.
NCT02424097 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02424097 about?
NCT02424097 is a clinical study titled "MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study". The objective of this clinical study is to evaluate the efficacy of multiple applications of MI Varnish in combination with MI Paste Plus in caries protection and remineralization in comparison to the use of a control (Crest 1,100ppm Fluoride tooth paste, Fluoride rinse recommendation) in orthodonti...
What is the current status of trial NCT02424097?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2013-05. Estimated completion is 2016-10.
What conditions does trial NCT02424097 study?
This clinical trial studies the following conditions: Dental Caries, Dental White Spots.
What interventions are being tested in trial NCT02424097?
The interventions under investigation include: CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste (DRUG), 1,100pm F-toothpaste and 0.5%NaF rinse (DRUG).
Who is sponsoring clinical trial NCT02424097?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02424097 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02424097's enrollment target sits among peer trials
40 21st of 30 higher than 10 of 30 other Dental Caries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dental Caries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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