NCT02194621

Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria

A Randomized, Single Center, Three Cell, Double Blind and Parallel Groups Clinical Study Conducted in Newark, NJ to Evaluate the Antibacterial Effects of Two Toothpastes Containing 0.3% Triclosan/2% Copolymer/0.243% Sodium Fluoride in a Silica Base as Compared to a Control Regular Fluoride Toothpaste on Oral Bacteria 12 Hours After 13 Days Product Use.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Colgate Palmolive · Industry
• Sex: All
• Age: 22 Years – 58 Years
• Healthy volunteers: Accepted

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.

Conditions

• Oral Bacteria Levels in the Mouth

Interventions

Type	Name	Description
DRUG	Total Flavor option 1	Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1
DRUG	Total Flavor option 2	Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2
DRUG	Placebo toothpaste: Crest Cavity Protection toothpaste	Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2014-07-18
• Last updated: 2016-04-15
• Results posted: 2016-04-15

Locations

1 site across 1 country: United States