Dental Plaque
Conditions
Brief summary
Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse
Detailed description
Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.
Interventions
DRUGFluoride
Brush half mouth twice daily for four days.
Brush twice daily
DRUGChlorhexidine Gluconate
Rinse mouth twice a day
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
* Be aged 18 to 65 years inclusive * Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present * Give written informed consent * Be in good general health * No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study * If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)
Exclusion criteria
* Medical condition which requires pre-medication (antibiotics) prior to dental * Visits/procedures * Allergy to chlorhexidine * Advanced periodontal disease (gum disease) * 5 or more decayed, untreated dental sites (cavities) * Diseases of the soft or hard oral tissues (gums or palate) * Orthodontic appliances that interfere with plaque rating * Abnormal salivary function * Use of drugs that can affect currently salivary flow or production * 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) * Pregnant or breastfeeding. * Participation in another research study in the month preceding this study * Allergic to common toothpaste or mouth rinse ingredients. * Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index | 4 Days | Plaque score is Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) |
Countries
United States
Participant flow
Recruitment details
Performed at the clinic
Participants by arm
| Arm | Count |
|---|---|
| Fluoride Toothpaste negative control toothpaste | 7 |
| Total Toothpaste triclosan/fluoride toothpaste (positive control) | 7 |
| Chlorhexidine Oral Rinse chlorhexidine oral rinse (positive control) | 8 |
| Total | 22 |
Baseline characteristics
| Characteristic | Total Toothpaste | Chlorhexidine Oral Rinse | Fluoride Toothpaste | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 8 Participants | 7 Participants | 22 Participants |
| Age Continuous | 50.5 years STANDARD_DEVIATION 6.5 | 56.6 years STANDARD_DEVIATION 5.5 | 44.2 years STANDARD_DEVIATION 10.23 | 50.43 years STANDARD_DEVIATION 8.86 |
| Region of Enrollment United States | 7 participants | 8 participants | 7 participants | 22 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 7 Participants | 20 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 1 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
Plaque Index
Plaque score is Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Time frame: 4 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride Toothpaste | Plaque Index | 3.31 Units on a scale | Standard Deviation 0.48 |
| Total Toothpaste | Plaque Index | 3.31 Units on a scale | Standard Deviation 0.38 |
| Chlorhexidine Oral Rinse | Plaque Index | 2.91 Units on a scale | Standard Deviation 0.36 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA