Dental Plaque
Conditions
Brief summary
To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.
Interventions
Rinse 3 times daily with assigned toothpaste slurry
DRUGfluoride
Rinse 3 times daily with assigned toothpaste slurry
DRUGFluoride, triclosan, amino acid
Rinse 3 times daily with assigned toothpaste slurry
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
72 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* Maxillary dentition is preferentially natural. * Maxillary restorations and/or reconstructions and eventual partial dentures must be in clinically good condition. * Natural mandibular front teeth and first premolars (4-4) are retained. * Second mandibular molars are ideally present to serve as abutment teeth. * Mandibular restorations and/or reconstructions must be in clinically good condition. * Partial mandibular denture replacing second premolars and first (and second) molars in good clinical condition. * Subjects should have a stimulated saliva flow rate of 1-2 ml/min (by chewing paraffin wax). * Willingness to give their informed consent and comply with the protocol. * No history of allergy to personal/oral care consumer products or ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
Exclusion criteria
* Current participation in other dental clinical trials. * Subjects who are unable to provide sufficient plaque growth over a 2-day non- brushing period (by visual assessment). * Subjects in whom the plaque pH fails to fall sufficiently, i.e. at least to pH 5 following a sucrose rinse. * Subjects with poor oral health, i.e. with advanced periodontitis, un-restored carious lesions and stomatological diseases. * Subjects taking drugs known to currently affect salivary flow. * Subjects with un-stimulated salivary flow \<0.3 ml/min and/or stimulated flow \<0.9 ml/min. * Women who are pregnant or breastfeeding * History of allergy to common dentifrice ingredients * Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) * Women of child bearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (intrauterine device) or condoms) * Medical condition which requires premedication prior to dental procedures/visits * History of allergy to amino acids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ph of Dental Plaque After Sucrose Challenge | 1 week | Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth. |
Countries
Switzerland
Participant flow
Recruitment details
subjects are recruited by the PI at the clinical site
Pre-assignment details
subjects are screened for medical and oral health criteria and start a 1 week washout period.
Participants by arm
| Arm | Count |
|---|---|
| Placebo First, Positive Control Second and Experimental Last | 2 |
| Positive Control First, Experimental Second and Placebo Last | 2 |
| Experimental First, Placebo Second and Positive Control Last | 2 |
| Total | 6 |
Baseline characteristics
| Characteristic | Positive Control First, Experimental Second and Placebo Last | Experimental First, Placebo Second and Positive Control Last | Placebo First, Positive Control Second and Experimental Last | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 77.5 years STANDARD_DEVIATION 0.7 | 73.5 years STANDARD_DEVIATION 2.1 | 76.5 years STANDARD_DEVIATION 3.5 | 75.8 years STANDARD_DEVIATION 2.6 |
| Region of Enrollment Switzerland | 2 participants | 2 participants | 2 participants | 6 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 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 / 2 | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 0 / 2 |
Outcome results
Primary
ph of Dental Plaque After Sucrose Challenge
Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Comparator | ph of Dental Plaque After Sucrose Challenge | 4.88 ph of dental plaque | Standard Deviation 0.38 |
| Placebo - Silica Control | ph of Dental Plaque After Sucrose Challenge | 5.04 ph of dental plaque | Standard Deviation 0.38 |
| Experimental Toothpaste | ph of Dental Plaque After Sucrose Challenge | 4.98 ph of dental plaque | Standard Deviation 0.24 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA