Conditions: Oral Bacteria Levels in the Mouth
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 128
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 1 ingredient - Total Flavor Option 1 arm 2: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 2 ingredient. Total Flavor Option 2 arm 3: Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)

Interventions: intervention 1: Total Flavor option 1 intervention 2: Total Flavor option 2 intervention 3: Placebo toothpaste: Crest Cavity Protection toothpaste
Intervention descriptions: intervention 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1 intervention 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2 intervention 3: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)

Protocol document: