Dental Plaque
Conditions
Keywords
Dental Plaque
Brief summary
The objective of this study was to evaluate the anti-plaque efficacy of the Anacor prototype dentrifice as compared to commercial control products following a single use of the dentrifice.
Detailed description
The widespread successful use of triclosan as an anti-inflammatory and anti-bacterial agent is well documented. The standard dentrifice has demonstrated a robust anti-plaque and anti-inflammatory effect providing multiple benefits. There is a clear value to identify additional agents with the same dual action with a comparable or an enhanced level of efficacy. This study examined the anti-plaque efficacy following a single use of the prototype dentifrice.
Interventions
OTHERNegative Control (Regular Toothpaste)
Regular Toothpaste
OTHERPositive Control (anti-plaque/anti-bacterial toothpaste)
Standard anti-plaque and anti-bacterial toothpaste
DRUGPrototype (AN0128 Toothpaste)
AN0128 Toothpaste
Sponsors
Pfizer
Study design
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be between ages 18 to 65 years inclusive * Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present * Must give written informed consent * Be in good general health * Must discontinue oral hygiene for 24-hours after initial appointment * No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
Exclusion criteria
* Medical condition which requires pre-medication prior to dental visits/procedures * Advanced periodontal disease * 5 or more decayed, untreated dental sites * Diseases of the soft or hard oral tissues * Orthodontic appliances * Abnormal salivary function * Use of drugs that can affect salivary flow * Use of antibiotics one (1) month prior to or during this study * Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxen), unless approved by the study medical staff * Pregnant or breastfeeding * Participation in another clinical study in the month preceding this study * Allergic to common dentifrice ingredients * Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) * History of allergic reaction to any anti-inflammatory agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing) | Baseline (time zero), 24 hour time point |
Countries
United States
Outcome results
None listed