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NCT02194621 · ClinicalTrials.gov registry record · Phase 4
Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria
A Phase 4 study, sponsored by Colgate Palmolive.
- Completed
- Registry status
- Phase 4
- Development phase
- 128
- Enrollment target
NCT02194621: Completed Phase 4 study, sponsored by Colgate Palmolive.
NCT02194621 is a Phase 4 study that has completed, run by Colgate Palmolive. The registered enrollment target is 128 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02194621, a Phase 4 study, has completed, sponsored by Colgate Palmolive.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 128 participants
- Enrollment target
Study Summary
The primary objective was to evaluate the antibacterial effects of two toothpastes containing 0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as compared to a control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours after 13 days of product use. A secondary objective was to demonstrate that a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234% sodium fluoride and a flavor with odor-masking ingredients in silica base (Colgate Total Toothpaste-Flavor Option 1) provides a level of antibacterial efficacy that is "equivalent" to a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234% sodium fluoride and a regular flavor in silica base (Colgate Total Toothpaste-Flavor Option 2) after 13 days of product use.
Primary Outcome
Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.
Interventions
- DRUG Total Flavor option 1
- DRUG Total Flavor option 2
- DRUG Placebo toothpaste: Crest Cavity Protection toothpaste
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
What the finished NCT02194621 record still lists
NCT02194621 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Total Flavor option 1 is the first listed.
NCT02194621 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02194621 about?
NCT02194621 is a clinical study titled "Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria". The primary objective was to evaluate the antibacterial effects of two toothpastes containing 0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as compared to a control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours after 13 days of product use. A secon...
What is the current status of trial NCT02194621?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 128 participants. The study started on 2014-01. Estimated completion is 2014-03.
What interventions are being tested in trial NCT02194621?
The interventions under investigation include: Total Flavor option 1 (DRUG), Total Flavor option 2 (DRUG), Placebo toothpaste: Crest Cavity Protection toothpaste (DRUG).
Who is sponsoring clinical trial NCT02194621?
This trial is sponsored by Colgate Palmolive, which has 51 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02194621's enrollment target sits among peer trials
128 634th of 2000 higher than 1,362 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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