Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria

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.

Timeline

Start

2014-01

Primary completion

2014-03

Completion

2014-03

Outcome

Mixed primary results

registry analysis (superiority or other test); Total Flavor Option 1 vs Total Flavor Option 2 vs Crest Toothpaste; p >0.05; ANOVA NCT02194621 ↗

registry analysis (superiority or other test); Total Flavor Option 2 vs Crest Toothpaste; p <0.001; ANCOVA NCT02194621 ↗

registry MEAN Total Flavor Option 2: 7.71 (Standard Error 0.09) colony forming units NCT02194621 ↗

registry MEAN Crest Toothpaste: 8.37 (Standard Error 0.09) colony forming units NCT02194621 ↗

registry analysis (superiority or other test); Total Flavor Option 1 vs Total Flavor Option 2 vs Crest Toothpaste; p = 0.002; ANCOVA NCT02194621 ↗

registry MEAN Total Flavor Option 1: 5.99 (Standard Error 0.07) colony forming units NCT02194621 ↗

registry MEAN Total Flavor Option 2: 5.92 (Standard Error 0.07) colony forming units NCT02194621 ↗

registry MEAN Crest Toothpaste: 6.32 (Standard Error 0.07) colony forming units NCT02194621 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Total Flavor option 1	Unknown	—	—
Subject	Total Flavor option 2	Unknown	—	—

Indications

No indication recorded.