A Clinical Study to Investigate Stannous Fluoride Toothpaste on Antibacterial Effects in the Different Regions of the Mouth as Compared to Colgate Cavity Protection Toothpaste
Overview
- Phase
- Phase 3
- Intervention
- Colgate Dental Cream
- Conditions
- Plaque, Dental
- Sponsor
- Colgate Palmolive
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Measurement of total bacterial counts in saliva
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This 4-week clinical study was designed to examine the antibacterial efficacy of brushing with a 0.454% stannous fluoride toothpaste with potassium nitrate and pyrophosphate compared to a toothpaste containing 0.76% MFP (marketed as Colgate Cavity Protection Toothpaste) in different regions of the mouth (dental plaque, tongue, cheek, gum surface and in saliva) 12 hours post-brushing (overnight) after 2 and 4 weeks of product use.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female subjects, ages 18-70, inclusive.
- •Subject is available during study duration and has no allergies to oral hygiene formulations.
- •A minimum of 20 natural teeth with facial and lingual scorable surfaces.
- •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 clinical examination schedules.
- •Subjects with a baseline whole mouth scores of dental plaque of 1.5 or more \[Turesky Modification of Quigley-Hein\] and gingivitis index of 1.0 or more \[Loe-Silness\].
Exclusion Criteria
- •Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study.
- •History of dental prophylaxis or treatments in the past month or during study duration.
- •History of medical treatments including antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding study enrollment.
- •Subjects scheduled for medical procedures for the duration of the study.
- •Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc.
- •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.
- •History of diabetes or hepatic or renal disease, or medical or inflammatory 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.
- •Oral soft tissue pathology.
- •History of active or severe periodontal disease and loose teeth.
Arms & Interventions
Group I
toothpaste brushing 2/day for 2 minutes
Intervention: Colgate Dental Cream
Group II
toothpaste brushing 2/day for 2 minutes
Intervention: Stannous fluoride toothpaste
Outcomes
Primary Outcomes
Measurement of total bacterial counts in saliva
Time Frame: baseline, 2 week & 4 week
Collected samples in saliva will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis
Measurement of total bacterial counts on cheek
Time Frame: baseline, 2 week & 4 week
Scrapings from the surface of the cheek mucosa. All collected samples will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis
Whole mouth scores of dental plaque
Time Frame: baseline, 2 week & 4 week
Measuring the dental plaque using the Turesky Modification of Quigley-Hein.Subjects presenting with whole mouth scores for dental plaque of 1.5 or more \[Turesky Modification of plaque will be enrolled. Quigley-Hein.
Measurement of total bacterial counts on tongue
Time Frame: baseline, 2 week & 4 week
Scrapings from the surface of the tongue. All collected samples will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis
Measurement of gingivitis
Time Frame: baseline, 2 week & 4 week
Using the Loe-Silness index.Subjects presening will 1.0 or more for gingivitis \[Loe-Silness\] will be enrolled.