Plaque, Dental
Conditions
Keywords
bacteria, plaque, saliva
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.
Interventions
product containing 0.45% stannous fluoride
DRUGColgate Dental Cream
product containing 0.76% sodium monofluorophosphate
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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. * Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations). * Fixed or removable orthodontic appliance or removable partial dentures. * Self-reported pregnancy or lactation. * Subjects known to be an alcoholic, or a recovering alcoholic. * History or current use of recreational drugs or other habit promoting products. * Use of phenolic flavored products, such as mint flavored candies and chewing gum, during the study period. * Ability to refrain from oral hygiene for twelve (12) hours prior to scheduled visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole mouth scores of dental plaque | 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 | 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 total bacterial counts on cheek | 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 |
| Measurement of gingivitis | baseline, 2 week & 4 week | Using the Loe-Silness index.Subjects presening will 1.0 or more for gingivitis \[Loe-Silness\] will be enrolled. |
| Measurement of total bacterial counts in saliva | 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 |
Countries
Thailand
Outcome results
None listed