Clinical trial NCT02194621: Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Bacteria Levels in the Mouth
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2014-07-18
Enrollment: 128
Sex: ALL
Minimum age (years): 22
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Males and females in good general health aged 18 to 70 years.
2. 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.
3. A minimum of 20 natural teeth with facial and lingual scorable surfaces.
4. Adequate oral hygiene and no signs of oral neglect.
5. Good periodontal health. Enrolled subjects will have no more than five periodontal pockets of 5 mm.
6. 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:

1. 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.
2. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars
3. History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.
4. History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
5. Subjects on antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
6. Significant oral soft tissue pathology, systemically related gingival enlargement, severe gingivitis (based on a visual examinations).
7. History of active severe periodontal disease with bleeding gums and loose teeth.
8. 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.
9. Fixed or removable orthodontic appliance or removable partial dentures.
10. 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.
11. Self reported pregnancy or lactation.
12. History or current use of objects to pierce the lips or tongue.
13. Subjects known to be an alcoholic, or a recovering alcoholic.
14. History or current use of recreational drugs.

Primary outcomes:
measure: Anaerobic Bacteria
timeFrame: Baseline
measure: Anaerobic Bacteria
timeFrame: 12 hours
measure: Malodor Bacteria (Breath Odor Causing Bacteria)
timeFrame: Baseline
measure: Malodor Bacteria (Breath Odor Causing Bacteria)
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers School of Dental Medicine
state: New Jersey
Study officials:
References: