Gingival Diseases
Conditions
Brief summary
Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.
Interventions
DRUGFluoride/triclosan
Brush daily for 3 weeks
Brush twice daily for 3 weeks
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 51 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female volunteers at least 20 - 51 years of age * Good general health * Must sign informed consent form * Minimum of 15 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) * 5 or more decayed untreated dental sites at screening (cavities) * 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 are currently affecting salivary function * 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 which interferes with plaque scoring * History of allergy to common toothpaste ingredients * History of allergy to arginine (amino acid) * Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental Plaque Index | 4 Day | Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque |
Countries
United States
Participant flow
Recruitment details
At clinical site
Participants by arm
| Arm | Count |
|---|---|
| Fluoride/Triclosan | 11 |
| Triclosan/Fluoride | 12 |
| Total | 23 |
Baseline characteristics
| Characteristic | Triclosan/Fluoride | 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 | 12 Participants | 11 Participants | 23 Participants |
| Age Continuous | 30.3 years STANDARD_DEVIATION 7.1 | 32.5 years STANDARD_DEVIATION 11.7 | 31.4 years STANDARD_DEVIATION 9.4 |
| Region of Enrollment United States | 12 participants | 11 participants | 23 participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 19 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 4 Participants |
Outcome results
Primary
Dental Plaque Index
Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque
Time frame: 4 Day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride/Triclosan | Dental Plaque Index | 2.48 Units on a scale | Standard Deviation 0.34 |
| Triclosan/Fluoride | Dental Plaque Index | 2.42 Units on a scale | Standard Deviation 0.39 |
p-value: 0.05ANOVA