Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Oral Bacteria Levels in the Mouth

Intervention / Treatment
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* Drug: Total Flavor option 1
* Drug: Total Flavor option 2
* Drug: Placebo toothpaste: Crest Cavity Protection toothpaste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females in good general health aged 18 to 70 years. A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and sampling schedules. A minimum of 20 natural teeth with facial and lingual scorable surfaces. Adequate oral hygiene and no signs of oral neglect. Good periodontal health. Enrolled subjects will have no more than five periodontal pockets of 5 mm. Subjects with gingival index greater than or equal to 1.0 (Loe-Silness Index) and plaque index greater than or equal to 1.5 (Turesky modification of Quigley-Hein Index) will be enrolled. Exclusion Criteria: History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS. History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures. Subjects on antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam. Significant oral soft tissue pathology, systemically related gingival enlargement, severe gingivitis (based on a visual examinations). History of active severe periodontal disease with bleeding gums and loose teeth. Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).will not be included in the tooth count. Fixed or removable orthodontic appliance or removable partial dentures. Participation in a dental plaque/gingivitis clinical study involving oral care products, within the last 30 days. History of dental prophylaxis or treatments in the past month. Self reported pregnancy or lactation. History or current use of objects to pierce the lips or tongue. Subjects known to be an alcoholic, or a recovering alcoholic. History or current use of recreational drugs.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 58 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total Flavor Option 1<br>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 1 ingredient - Total Flavor Option 1 | Drug: Total Flavor option 1<br>* Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1<br>* Other names: Total toothpaste;|
| Experimental: Total Flavor Option 2<br>Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 2 ingredient. Total Flavor Option 2 | Drug: Total Flavor option 2<br>* Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2<br>* Other names: Total toothpaste;|
| Placebo Comparator: Crest Toothpaste<br>Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed) | Drug: Placebo toothpaste: Crest Cavity Protection toothpaste<br>* Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)<br>* Other names: Crest Anti-Cavity toothpaste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anaerobic Bacteria | 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. | Baseline | 
| Anaerobic Bacteria | 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. | 12 hours | 
| Malodor Bacteria (Breath Odor Causing Bacteria) | 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 levels of mouth odor causing bacteria CFU - colony forming units. | Baseline | 
| Malodor Bacteria (Breath Odor Causing Bacteria) | 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 levels of mouth odor causing bacteria CFU - colony forming units. | 12 hours |