Dental Plaque
Conditions
Brief summary
This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.
Detailed description
Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.
Interventions
DRUGFluoride
Brush two times a day for 4 days.
Brush two times daily for 4 days
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 53 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female volunteers at least 18 - 53 years of age * Good general health * Must sign informed consent form * 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 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 dentifrice ingredients. * History of allergy to arginine (amino acid) * History of allergy to bicarbonate * 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. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque. |
Countries
United States
Participant flow
Recruitment details
At clinical site
Participants by arm
| Arm | Count |
|---|---|
| Fluoride - A Negative control | 8 |
| Fluoride/Triclosan - B Positive control comparator | 7 |
| Triclosan/Fluoride/Arginine toothpaste containing amino acid | 6 |
| Triclosan/Fluoride/Cavistat toothpaste containing bicarbonate | 8 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 2nd Intervention Order | Lost to Follow-up | 0 | 1 | 0 | 0 |
| 3rd Intervention | Lost to Follow-up | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Fluoride/Triclosan - B | Triclosan/Fluoride/Arginine | Fluoride - A | Triclosan/Fluoride/Cavistat | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 6 Participants | 8 Participants | 8 Participants | 29 Participants |
| Age Continuous | 29.7 years STANDARD_DEVIATION 8.7 | 36.4 years STANDARD_DEVIATION 11.6 | 30.5 years STANDARD_DEVIATION 10.8 | 37.8 years STANDARD_DEVIATION 5 | 33.6 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment United States | 7 participants | 6 participants | 8 participants | 8 participants | 29 participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 6 Participants | 4 Participants | 23 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 29 | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 | 0 / 29 | 0 / 29 |
Outcome results
Primary
Dental Plaque Index
plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.
Time frame: 4-Day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride - A | Dental Plaque Index | 3.12 Units on a scale | Standard Deviation 0.38 |
| Fluoride/Triclosan - B | Dental Plaque Index | 2.90 Units on a scale | Standard Deviation 0.36 |
| Triclosan/Fluoride/Arginine | Dental Plaque Index | 2.92 Units on a scale | Standard Deviation 0.42 |
| Triclosan/Fluoride/Cavistat | Dental Plaque Index | 2.94 Units on a scale | Standard Deviation 0.42 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: <0.05ANOVA