Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria (NCT02194621) | Clinical Trial Compass
CompletedPhase 4
Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria
United States128 participantsStarted 2014-01
Plain-language 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.
Who can participate
Age range22 Years – 58 Years
SexALL
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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.