Salivary Bacteria Levels
Conditions
Brief summary
Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing
Interventions
DRUGFluoride
Whole mouth brushing for 7 days
Brush whole mouth twice daily for 7 days
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
* Male or female volunteers 18-65 years of age * Good general health * Must sign informed consent form * Must discontinue oral hygiene on the mornings of each appointment and between sampling periods. * 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
* Medical condition which requires pre-medication prior to dental procedures/visits * Medical condition which precludes eating/drinking for 12 hrs. * History of allergy to common dentifrice ingredients * Subjects unable or unwilling to sign the informed consent form. * Moderate or advanced periodontal disease. * 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 currently affect salivary flow * Current use of antibiotics * 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 30 days 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. * Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CFU (Colony Forming Units) | 4 hours | Total number of salivary bacterial colony forming units (lower number = less colonies present) |
Countries
India
Participant flow
Recruitment details
At clinical site
Participants by arm
| Arm | Count |
|---|---|
| Fluoride 1st, Triclosan/Fluoride 2nd Fluoride toothpaste (placebo) | 11 |
| Triclosan/Fluoride 1st, Fluoride 2nd Triclosan/Fluoride toothpaste (experimental) | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | Triclosan/Fluoride 1st, Fluoride 2nd | Fluoride 1st, Triclosan/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 | 11 Participants | 11 Participants | 22 Participants |
| Age Continuous | 30.5 years STANDARD_DEVIATION 8.7 | 30.8 years STANDARD_DEVIATION 6.8 | 30.6 years STANDARD_DEVIATION 7.6 |
| Region of Enrollment India | 11 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
CFU (Colony Forming Units)
Total number of salivary bacterial colony forming units (lower number = less colonies present)
Time frame: 4 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride Toothpaste (Control) | CFU (Colony Forming Units) | 7.18 number of colony forming units | Standard Deviation 0.61 |
| Triclosan/Fluoride Toothpaste | CFU (Colony Forming Units) | 6.94 number of colony forming units | Standard Deviation 0.4 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA