Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria
Completed · Phase 4 · Has a placebo group
Conditions studied: Oral Bacteria Levels in the Mouth
In brief
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.
Key facts
- Study ID
- NCT02194621
- Run by
- Colgate Palmolive
- People needed
- 128
- Starts
- 2014-01-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2016-04-15
Who can join
Age: 22 and older, up to 58. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Rutgers School of Dental Medicine — Newark, New Jersey, United States
Full record on ClinicalTrials.gov
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