Plaque, Gingivitis
Conditions
Brief summary
The clinical study will examine the effects of brushing with randomly assigned test toothpaste on the bacteria on the dental plaque, tongue, cheek, gum surface, and in saliva
Detailed description
This parallel design clinical study will examine the effects of brushing with randomly assigned test toothpaste on the bacteria on the dental plaque, tongue, cheek, gum surface, and in saliva. The effects of the test toothpaste will be compared to a commercially available fluoride dentifrice that will serve as a control.
Interventions
toothpaste
toothpaste
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 mouth rinses. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loe-Silness | baseline, 2 week and 4 week | gingivitis index of 1.0 or more |
| Turesky Modification of Quigley-Hein | baseline, 2 week and 4 week | whole mouth scores of dental plaque of 1.5 or more |
Contacts
CONTACTTerdphong Triratana, DDS
CONTACTPhraekhun Kanjanakuha
Outcome results
None listed