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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 is a Phase 4 study that has completed, run by Colgate Palmolive. The registered enrollment target is 128 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02194621
The ClinicalTrials.gov registry entry for NCT02194621 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Colgate Palmolive, which has 51 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Total Flavor option 1 is the first listed.
NCT02194621 reports 0 study locations.
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.
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