Dental Plaque
Conditions
Brief summary
Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.
Interventions
Brush teeth and evaluate plaque score after one use of the study toothpaste
DRUGTriclosan/Fluoride/Copolymer
Brush teeth and evaluate plaque score after one use of the study toothpaste
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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 20 natural uncrowned teeth (excluding 3rd molars) present * Give written informed consent * Be in good general health * Must discontinue oral hygiene for 24-hrs.after initial appointment. * 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
Exclusion criteria
* Medical condition which requires pre-medication prior to dental visits/procedures * Advanced periodontal disease * 5 or more decayed, untreated dental sites * Diseases of the soft or hard oral tissues * Orthodontic appliances * Abnormal salivary function * Use of drugs that can currently 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) * Pregnant or breastfeeding. * Participation in another clinical study in the month preceding this study * Allergic to common dentifrice ingredients. * Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Margin Plaque Index | 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). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment. |
Countries
United States
Participant flow
Recruitment details
At clinical site
Participants by arm
| Arm | Count |
|---|---|
| Fluoride 1st, Then Triclosan +Fluoride 2nd Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment. | 10 |
| Triclosan + Fluoride 1st, Then Fluoride 2nd Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment. | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (1 Day) | Physician Decision | 1 | 0 |
| First Intervention (1 Day) | Screening failure | 1 | 0 |
| First Intervention (1 Day) | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Fluoride 1st, Then Triclosan +Fluoride 2nd | Triclosan + Fluoride 1st, Then Fluoride 2nd | 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 | 9 Participants | 19 Participants |
| Age Continuous | 32.1 years STANDARD_DEVIATION 11.14 | 33 years STANDARD_DEVIATION 8.7 | 32.53 years STANDARD_DEVIATION 9.78 |
| Region of Enrollment United States | 10 participants | 9 participants | 19 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 17 |
Outcome results
Primary
Gingival Margin Plaque Index
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). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride | Gingival Margin Plaque Index | 15.4 Units on a scale | Standard Deviation 14.74 |
| Triclosan + Fluoride | Gingival Margin Plaque Index | 12.81 Units on a scale | Standard Deviation 14.06 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA