Oral Bacteria
Conditions
Brief summary
To compare the antimicrobial efficacy of three dentifrices on oral bacteria
Interventions
DRUGFluoride
Brush twice a day for 14 days
Brush twice daily for 14 days
DRUGStannous Fluoride
Brush twice daily for 14 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 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females in good general health aged 18 to 70 years. * A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and sampling schedules. * A minimum of 20 natural teeth with facial and lingual scorable surfaces. * Adequate oral hygiene and no signs of oral neglect. * Good periodontal health. Enrolled subjects will have periodontal pockets no greater than 5 mm. * Gingival and plaque indices will also be measured during the first visit. Subjects with gingival index greater than or equal to 1.5 (Lobene Index) and plaque index greater than or equal to 1.5 (Turesky modification of Quigley-Hein Index) will be enrolled.
Exclusion criteria
* History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients. Previous known allergy to dental materials, particularly to acrylic-like materials used to fabricate the stent device (this is a highly unlikely occurrence). * Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars * Difficulty having dental impressions taken such as excessive gagging. * History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS. * History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures. * Subjects on antibiotic, antiinflammatory or anticoagulant therapy during the month preceding the baseline exam. * Significant oral soft tissue pathology, systemically related gingival enlargement, severe gingivitis (based on a visual examinations). * History of active severe periodontal disease with bleeding gums and loose teeth. * Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).will not be included in the tooth count. * Fixed or removable orthodontic appliance or removable partial dentures. * Participation in a dental plaque/gingivitis clinical study involving oral care products, within the last 30 days. History of dental prophylaxis or treatments in the past month. * Self reported pregnancy or lactation. * History or current use of objects to pierce the lips or tongue. * Subjects known to be an alcoholic, or a recovering alcoholic. * History or current use of recreational drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antimicrobial Species in Plaque(Actinomyces) | 14 days | After 14 days of study product use, dental plaque was scraped from the subject's teeth. The plaque was placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar |
| Antimicrobial Species in Saliva(Actinomyces) | 14 days | Saliva was collected, after 14 days of product use, by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar |
| Antimicrobial Species on the Tongue(Actinomycetes) | 14 days | After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar |
| Antimicrobial Species on the Cheek(Actinomyces) | 14 days | After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar |
| Antimicrobial Species in Plaque(Total Anaerobic) | 14 days | After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar |
| Antimicrobial Species in Saliva(Total Anaerobic) | 14 days | After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar |
| Antimicrobial Species in Tongue(Total Anaerobic) | 14 days | After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar. |
| Antimicrobial Species on the Cheek(Total Anaerobic) | 14 days | After 14 day of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar. |
| Antimicrobial Species in Plaque(Fusobacteria) | 14 days | After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar. |
| Antimicrobial Species in Saliva(Fusobacteria) | 14 days | After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar. |
| Antimicrobial Species in Tongue(Fusobacteria) | 14 days | After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar. |
| Antimicrobial Species on the Cheek(Fusobacteria) | 14 days | After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar. |
| Antimicrobial Species in Plaque(Oral Streptococci) | 14 days | After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar. |
| Antimicrobial Species in Saliva(Oral Streptococci) | 14 days | After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar. |
| Antimicrobial Species in Tongue(Oral Streptococci) | 14 days | After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar. |
| Antimicrobial Species on the Cheek(Oral Streptococci) | 14 days | After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar |
| Antimicrobial Species in Plaque(Sulfur Bacteria) | 14 days | After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar. |
| Antimicrobial Species in Saliva(Sulfur Bacteria) | 14 days | After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar. |
| Antimicrobial Species in Tongue(Sulfur Bacteria) | 14 days | After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar. |
| Antimicrobial Species on the Cheek(Sulfur Bacteria) | 14 days | After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar. |
| Antimicrobial Species in Plaque(Veillonella) | 14 days | After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar. |
| Antimicrobial Species in Saliva(Veillonella) | 14 days | After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on veillonella Agar. |
| Antimicrobial Species in Tongue(Veillonella) | 14 days | After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar. |
| Antimicrobial Species on the Cheek(Veillonella) | 14 days | After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar. |
Countries
United States
Participant flow
Recruitment details
subjects were recruited by the PI at the clinical site
Pre-assignment details
Subjects were screened for medical and oral health criteria and then entered a 1 week washout.
Participants by arm
| Arm | Count |
|---|---|
| Placebo 1st, Active Comparator 2nd and Experimental 3rd Participants brushed their teeth with the placebo control (fluoride toothpaste only)during the first intervention then brushed with active comparator(fluoride/triclosan/copolymer toothpaste) during the second intervention and experimental product (stannous fluoride toothpaste) during as the last intervention. | 8 |
| Active Comparator 1st, Experimental 2nd, Placebo 3rd Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste)during the first intervention, then brushed with experimental product (stannous fluoride toothpaste) during the second intervention, and brushed with the placebo control (fluoride toothpaste only)as the last intervention. | 8 |
| Experimental 1st, Placebo 2nd, Active Comparator 3rd Participants brushed their teeth with the experimental product (stannous fluoride toothpaste) during the first intervention, then brushed with the placebo control (fluoride toothpaste only) during the second intervention and Active Comparator(fluoride/triclosan/copolymer toothpaste)as the last intervention. | 8 |
| Total | 24 |
Baseline characteristics
| Characteristic | Experimental 1st, Placebo 2nd, Active Comparator 3rd | Total | Placebo 1st, Active Comparator 2nd and Experimental 3rd | Active Comparator 1st, Experimental 2nd, Placebo 3rd |
|---|---|---|---|---|
| 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 | 8 Participants | 24 Participants | 8 Participants | 8 Participants |
| Age Continuous | 36.5 years STANDARD_DEVIATION 7.46 | 38.83 years STANDARD_DEVIATION 9.03 | 39.87 years STANDARD_DEVIATION 10.72 | 40.12 years STANDARD_DEVIATION 9.38 |
| Region of Enrollment United States | 8 participants | 24 participants | 8 participants | 8 participants |
| Sex: Female, Male Female | 4 Participants | 16 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 1 Participants | 3 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 / 24 | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
Primary
Antimicrobial Species in Plaque(Actinomyces)
After 14 days of study product use, dental plaque was scraped from the subject's teeth. The plaque was placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Plaque(Actinomyces) | 0.023 log CFU (Colony forming units) | Standard Error 0.0478 |
| Active Comparator | Antimicrobial Species in Plaque(Actinomyces) | 0.3881 log CFU (Colony forming units) | Standard Error 0.322 |
| Experimental | Antimicrobial Species in Plaque(Actinomyces) | 0.0538 log CFU (Colony forming units) | Standard Error 0.0247 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Plaque(Fusobacteria)
After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Plaque(Fusobacteria) | -0.2973 log CFU (Colony forming units) | Standard Error 0.0503 |
| Active Comparator | Antimicrobial Species in Plaque(Fusobacteria) | 0.2703 log CFU (Colony forming units) | Standard Error 0.0431 |
| Experimental | Antimicrobial Species in Plaque(Fusobacteria) | -0.0095 log CFU (Colony forming units) | Standard Error 0.038 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Plaque(Oral Streptococci)
After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Plaque(Oral Streptococci) | -0.0848 log CFU (Colony forming units) | Standard Error 0.0417 |
| Active Comparator | Antimicrobial Species in Plaque(Oral Streptococci) | 0.2593 log CFU (Colony forming units) | Standard Error 0.043 |
| Experimental | Antimicrobial Species in Plaque(Oral Streptococci) | -0.0096 log CFU (Colony forming units) | Standard Error 0.0358 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Plaque(Sulfur Bacteria)
After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Plaque(Sulfur Bacteria) | 0.0174 log CFU (Colony forming units) | Standard Error 0.0625 |
| Active Comparator | Antimicrobial Species in Plaque(Sulfur Bacteria) | 0.3083 log CFU (Colony forming units) | Standard Error 0.0424 |
| Experimental | Antimicrobial Species in Plaque(Sulfur Bacteria) | -0.0416 log CFU (Colony forming units) | Standard Error 0.057 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Plaque(Total Anaerobic)
After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Plaque(Total Anaerobic) | -0.0629 log CFU (Colony forming units) | Standard Error 0.0475 |
| Active Comparator | Antimicrobial Species in Plaque(Total Anaerobic) | 0.312 log CFU (Colony forming units) | Standard Error 0.0404 |
| Experimental | Antimicrobial Species in Plaque(Total Anaerobic) | 0.0762 log CFU (Colony forming units) | Standard Error 0.0547 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Plaque(Veillonella)
After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Plaque(Veillonella) | 0.0007 log CFU (Colony forming units) | Standard Error 0.0478 |
| Active Comparator | Antimicrobial Species in Plaque(Veillonella) | 0.3658 log CFU (Colony forming units) | Standard Error 0.0322 |
| Experimental | Antimicrobial Species in Plaque(Veillonella) | 0.0316 log CFU (Colony forming units) | Standard Error 0.0247 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Saliva(Actinomyces)
Saliva was collected, after 14 days of product use, by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Saliva(Actinomyces) | 0.016 log CFU (Colony forming units) | Standard Error 0.0236 |
| Active Comparator | Antimicrobial Species in Saliva(Actinomyces) | 0.3209 log CFU (Colony forming units) | Standard Error 0.0301 |
| Experimental | Antimicrobial Species in Saliva(Actinomyces) | 0.1116 log CFU (Colony forming units) | Standard Error 0.0272 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Saliva(Fusobacteria)
After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Saliva(Fusobacteria) | -0.0096 log CFU (Colony forming units) | Standard Error 0.0265 |
| Active Comparator | Antimicrobial Species in Saliva(Fusobacteria) | 0.194 log CFU (Colony forming units) | Standard Error 0.0356 |
| Experimental | Antimicrobial Species in Saliva(Fusobacteria) | 0.0539 log CFU (Colony forming units) | Standard Error 0.0311 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Saliva(Oral Streptococci)
After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Saliva(Oral Streptococci) | -0.0436 log CFU (Colony forming units) | Standard Error 0.0307 |
| Active Comparator | Antimicrobial Species in Saliva(Oral Streptococci) | 0.1445 log CFU (Colony forming units) | Standard Error 0.0305 |
| Experimental | Antimicrobial Species in Saliva(Oral Streptococci) | 0.087 log CFU (Colony forming units) | Standard Error 0.026 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Saliva(Sulfur Bacteria)
After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Saliva(Sulfur Bacteria) | -0.1213 log CFU (Colony forming units) | Standard Error 0.0494 |
| Active Comparator | Antimicrobial Species in Saliva(Sulfur Bacteria) | 0.1556 log CFU (Colony forming units) | Standard Error 0.0375 |
| Experimental | Antimicrobial Species in Saliva(Sulfur Bacteria) | -0.603 log CFU (Colony forming units) | Standard Error 0.0315 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Saliva(Total Anaerobic)
After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Saliva(Total Anaerobic) | -0.0247 log CFU (Colony forming units) | Standard Error 0.0266 |
| Active Comparator | Antimicrobial Species in Saliva(Total Anaerobic) | 0.1505 log CFU (Colony forming units) | Standard Error 0.0298 |
| Experimental | Antimicrobial Species in Saliva(Total Anaerobic) | 0.05 log CFU (Colony forming units) | Standard Error 0.0331 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Saliva(Veillonella)
After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on veillonella Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Saliva(Veillonella) | 0.0167 log CFU (Colony forming units) | Standard Error 0.0213 |
| Active Comparator | Antimicrobial Species in Saliva(Veillonella) | 0.3062 log CFU (Colony forming units) | Standard Error 0.0305 |
| Experimental | Antimicrobial Species in Saliva(Veillonella) | 0.0901 log CFU (Colony forming units) | Standard Error 0.0261 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Tongue(Fusobacteria)
After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Tongue(Fusobacteria) | -0.0742 log CFU (Colony forming units) | Standard Error 0.0416 |
| Active Comparator | Antimicrobial Species in Tongue(Fusobacteria) | 0.377 log CFU (Colony forming units) | Standard Error 0.0495 |
| Experimental | Antimicrobial Species in Tongue(Fusobacteria) | 0.1668 log CFU (Colony forming units) | Standard Error 0.048 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Tongue(Oral Streptococci)
After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Tongue(Oral Streptococci) | -0.1284 log CFU (Colony forming units) | Standard Error 0.0537 |
| Active Comparator | Antimicrobial Species in Tongue(Oral Streptococci) | 0.2233 log CFU (Colony forming units) | Standard Error 0.0355 |
| Experimental | Antimicrobial Species in Tongue(Oral Streptococci) | 0.0525 log CFU (Colony forming units) | Standard Error 0.0358 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Tongue(Sulfur Bacteria)
After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Tongue(Sulfur Bacteria) | -0.083 log CFU (Colony forming units) | Standard Error 0.0564 |
| Active Comparator | Antimicrobial Species in Tongue(Sulfur Bacteria) | 0.2065 log CFU (Colony forming units) | Standard Error 0.0474 |
| Experimental | Antimicrobial Species in Tongue(Sulfur Bacteria) | -0.0248 log CFU (Colony forming units) | Standard Error 0.0511 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Tongue(Total Anaerobic)
After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Tongue(Total Anaerobic) | -0.0445 log CFU (Colony forming units) | Standard Error 0.0508 |
| Active Comparator | Antimicrobial Species in Tongue(Total Anaerobic) | 0.2691 log CFU (Colony forming units) | Standard Error 0.0403 |
| Experimental | Antimicrobial Species in Tongue(Total Anaerobic) | 0.0926 log CFU (Colony forming units) | Standard Error 0.0334 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species in Tongue(Veillonella)
After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species in Tongue(Veillonella) | -0.002 log CFU (Colony forming units) | Standard Error 0.0229 |
| Active Comparator | Antimicrobial Species in Tongue(Veillonella) | 0.2724 log CFU (Colony forming units) | Standard Error 0.0402 |
| Experimental | Antimicrobial Species in Tongue(Veillonella) | -0.0424 log CFU (Colony forming units) | Standard Error 0.0262 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species on the Cheek(Actinomyces)
After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species on the Cheek(Actinomyces) | 0.0099 log CFU (Colony forming units) | Standard Error 0.027 |
| Active Comparator | Antimicrobial Species on the Cheek(Actinomyces) | 0.2949 log CFU (Colony forming units) | Standard Error 0.0327 |
| Experimental | Antimicrobial Species on the Cheek(Actinomyces) | -0.1875 log CFU (Colony forming units) | Standard Error 0.0354 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species on the Cheek(Fusobacteria)
After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species on the Cheek(Fusobacteria) | -0.0319 log CFU (Colony forming units) | Standard Error 0.0458 |
| Active Comparator | Antimicrobial Species on the Cheek(Fusobacteria) | 0.1887 log CFU (Colony forming units) | Standard Error 0.0251 |
| Experimental | Antimicrobial Species on the Cheek(Fusobacteria) | 0.111 log CFU (Colony forming units) | Standard Error 0.0265 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species on the Cheek(Oral Streptococci)
After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species on the Cheek(Oral Streptococci) | 0.0126 log CFU (Colony forming units) | Standard Error 0.0326 |
| Active Comparator | Antimicrobial Species on the Cheek(Oral Streptococci) | 0.2088 log CFU (Colony forming units) | Standard Error 0.0388 |
| Experimental | Antimicrobial Species on the Cheek(Oral Streptococci) | -0.0251 log CFU (Colony forming units) | Standard Error 0.0309 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species on the Cheek(Sulfur Bacteria)
After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species on the Cheek(Sulfur Bacteria) | -0.1788 log CFU (Colony forming units) | Standard Error 0.0362 |
| Active Comparator | Antimicrobial Species on the Cheek(Sulfur Bacteria) | 0.2036 log CFU (Colony forming units) | Standard Error 0.0581 |
| Experimental | Antimicrobial Species on the Cheek(Sulfur Bacteria) | -0.0815 log CFU (Colony forming units) | Standard Error 0.0373 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species on the Cheek(Total Anaerobic)
After 14 day of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species on the Cheek(Total Anaerobic) | -0.0551 log CFU (Colony forming units) | Standard Error 0.0259 |
| Active Comparator | Antimicrobial Species on the Cheek(Total Anaerobic) | 0.2009 log CFU (Colony forming units) | Standard Error 0.038 |
| Experimental | Antimicrobial Species on the Cheek(Total Anaerobic) | -0.0531 log CFU (Colony forming units) | Standard Error 0.0346 |
Comparison: the tongue will be scrapped 5 times with the edge of a tongue depressor. The depressor is vortex in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agarp-value: 0.05ANCOVA
Primary
Antimicrobial Species on the Cheek(Veillonella)
After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species on the Cheek(Veillonella) | -0.0732 log CFU (Colony forming units) | Standard Error 0.0351 |
| Active Comparator | Antimicrobial Species on the Cheek(Veillonella) | 0.2579 log CFU (Colony forming units) | Standard Error 0.0426 |
| Experimental | Antimicrobial Species on the Cheek(Veillonella) | -0.0676 log CFU (Colony forming units) | Standard Error 0.0294 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Antimicrobial Species on the Tongue(Actinomycetes)
After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar
Time frame: 14 days
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Toothpaste | Antimicrobial Species on the Tongue(Actinomycetes) | -0.0132 log CFU (Colony forming units) | Standard Error 0.0229 |
| Active Comparator | Antimicrobial Species on the Tongue(Actinomycetes) | 0.2612 log CFU (Colony forming units) | Standard Error 0.0402 |
| Experimental | Antimicrobial Species on the Tongue(Actinomycetes) | -0.0536 log CFU (Colony forming units) | Standard Error 0.0262 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA