Dental Plaque
Conditions
Brief summary
The purpose of this study is to train new examiners while testing two commercial products using our standard one-day brushing study regimen by measuring gingival margin plaque index.
Interventions
DRUGFluoride
Brush twice daily
Brush twice daily
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 volunteers 18-65 years of age * Good general health * Must sign informed consent form * Must discontinue oral hygiene for 24-hrs.after initial appointment. * Minimum of 20 natural uncrowned teeth (excluding third molars) must be present. * No 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
* Subjects unable or unwilling to sign the informed consent form. * Medical condition which requires pre-medication prior to dental visits/procedures * Moderate or advanced periodontal disease or heavy dental tartar (calculus). * 2 or more decayed untreated dental sites at screening. * Other disease of the hard or soft oral tissues. * Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation). * Use of medications that can affect salivary flow * Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1. * Pregnant or nursing women. * Participation in any other clinical study within 1 week prior to enrollment into this study. * Use of tobacco products * Subjects who must receive dental treatment during the study dates. * Current use of Antibiotics for any purpose. * Presence of an orthodontic appliance. * History of allergy to common dentifrice ingredients. * Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Gingival Plaque Units | 1 day | Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). |
Countries
United States
Participant flow
Recruitment details
At clinical site
Participants by arm
| Arm | Count |
|---|---|
| Fluoride | 7 |
| Triclosan | 8 |
| Total | 15 |
Baseline characteristics
| Characteristic | Fluoride | Triclosan | 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 | 7 Participants | 8 Participants | 15 Participants |
| Age Continuous | 34.3 years STANDARD_DEVIATION 17.4 | 32.1 years STANDARD_DEVIATION 11.5 | 33.1 years STANDARD_DEVIATION 14.1 |
| Region of Enrollment United States | 7 participants | 8 participants | 15 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Outcome results
Primary
Mean Gingival Plaque Units
Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque).
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride | Mean Gingival Plaque Units | 13.38 Units on a scale | Standard Deviation 13.65 |
| Triclosan | Mean Gingival Plaque Units | 14.29 Units on a scale | Standard Deviation 12.25 |
p-value: 0.05ANOVA