Phase 4
N=128
Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria
Oral Bacteria Levels in the Mouth
Bottom Line
View on ClinicalTrials.gov: NCT02194621 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Anaerobic Bacteria — 8.40; 8.42; 8.43 colony forming units — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Total Flavor option 1 (Drug); Total Flavor option 2 (Drug); Placebo toothpaste: Crest Cavity Protection toothpaste (Drug)
- Age
- Adult · 22+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anaerobic Bacteria |
7.68; 7.71; 8.37 | <0.001 sig |
| PRIMARY Anaerobic Bacteria |
7.68; 7.71; 8.37 | <0.001 sig |
| PRIMARY Malodor Bacteria (Breath Odor Causing Bacteria) |
5.99; 5.92; 6.32 | 0.002 sig |
| PRIMARY Malodor Bacteria (Breath Odor Causing Bacteria) |
5.99; 5.92; 6.32 | 0.002 sig |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT02194621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.