Dental Plaque
Conditions
Brief summary
The objective is to develop a method to determine active ingredient uptake in oral care products.
Interventions
DRUGFluoride
Brush half mouth once with assigned study treatment
DRUGFluoride and triclosan
Brush half mouth once with assigned study treatment
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female volunteer 18 - 65 years of age (inclusive). * Good general health with a minimum of twenty (20) natural, uncrowned teeth (excluding third molars) * Able and willing to sign the informed consent form. * Plaque score of at least 1.5 on the modified Quigley-Hein plaque index. * 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 procedures/visits * Medical condition which precludes not eating/drinking for 2 hours * Advanced periodontal disease (gum disease) * 5 or more decayed, untreated dental sites (cavities) * 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, naproxyn, etc) * Pregnant or breastfeeding. * Participation in another clinical study in the month preceding this study * Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Triclosan Concentration in Dental Plaque | 12 hours | Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards. |
Countries
Thailand
Participant flow
Recruitment details
subjects were recruited by the PI at the clinical site
Pre-assignment details
Subjects were screened for medical and oral health criteria and then began a 1 week washout period with fluoride toothpaste.
Participants by arm
| Arm | Count |
|---|---|
| Placebo First, Active Second subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention. | 10 |
| Active Toothpaste First, Then Placebo Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Active Toothpaste First, Then Placebo | Placebo First, Active Second | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age Continuous | 35.6 years STANDARD_DEVIATION 9.9 | 35.9 years STANDARD_DEVIATION 11.9 | 35.8 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment Thailand | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Triclosan Concentration in Dental Plaque
Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.
Time frame: 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride Toothpaste (Placebo) | Triclosan Concentration in Dental Plaque | 0 ppm levels of triclosan | Standard Deviation 0 |
| Active Toothpaste | Triclosan Concentration in Dental Plaque | 1.8 ppm levels of triclosan | Standard Deviation 1.2 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA