Oral Bacteria Levels in the Mouth
Conditions
Brief summary
The primary objective was to evaluate the antibacterial effects of two toothpastes containing 0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as compared to a control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours after 13 days of product use. A secondary objective was to demonstrate that a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234% sodium fluoride and a flavor with odor-masking ingredients in silica base (Colgate Total Toothpaste-Flavor Option 1) provides a level of antibacterial efficacy that is equivalent to a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234% sodium fluoride and a regular flavor in silica base (Colgate Total Toothpaste-Flavor Option 2) after 13 days of product use.
Interventions
DRUGTotal Flavor option 1
Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1
DRUGTotal Flavor option 2
Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2
DRUGPlacebo toothpaste: Crest Cavity Protection toothpaste
Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Years to 58 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females in good general health aged 18 to 70 years. 2. 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. 3. A minimum of 20 natural teeth with facial and lingual scorable surfaces. 4. Adequate oral hygiene and no signs of oral neglect. 5. Good periodontal health. Enrolled subjects will have no more than five periodontal pockets of 5 mm. 6. Subjects with gingival index greater than or equal to 1.0 (Loe-Silness Index) and plaque index greater than or equal to 1.5 (Turesky modification of Quigley-Hein Index) will be enrolled.
Exclusion criteria
1. 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. 2. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars 3. History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS. 4. History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures. 5. Subjects on antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam. 6. Significant oral soft tissue pathology, systemically related gingival enlargement, severe gingivitis (based on a visual examinations). 7. History of active severe periodontal disease with bleeding gums and loose teeth. 8. 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. 9. Fixed or removable orthodontic appliance or removable partial dentures. 10. 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. 11. Self reported pregnancy or lactation. 12. History or current use of objects to pierce the lips or tongue. 13. Subjects known to be an alcoholic, or a recovering alcoholic. 14. History or current use of recreational drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Malodor Bacteria (Breath Odor Causing Bacteria) | Baseline | Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units. |
| Anaerobic Bacteria | Baseline | Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units. |
Countries
United States
Participant flow
Recruitment details
subject recruitment is completed locally at the clinical site
Pre-assignment details
There will be a one (1) week wash out phase with commercially available fluoride toothpaste prior to any study intervention being assigned.
Participants by arm
| Arm | Count |
|---|---|
| Total Flavor Option 1 Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1
Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1 | 43 |
| Total Flavor Option 2 Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2
Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2 | 42 |
| Crest Toothpaste Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)
Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed) | 43 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | 6 withdrew prior to randomization | 2 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 4 | 7 |
Baseline characteristics
| Characteristic | Total Flavor Option 1 | Total Flavor Option 2 | Crest Toothpaste | Total |
|---|---|---|---|---|
| Age, Continuous | 36.6 years STANDARD_DEVIATION 10.2 | 34.2 years STANDARD_DEVIATION 10.34 | 35.9 years STANDARD_DEVIATION 12.08 | 35.4 years STANDARD_DEVIATION 10.82 |
| Region of Enrollment United States | 43 participants | 42 participants | 43 participants | 128 participants |
| Sex: Female, Male Female | 28 Participants | 29 Participants | 24 Participants | 81 Participants |
| Sex: Female, Male Male | 15 Participants | 13 Participants | 19 Participants | 47 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 / 43 | 0 / 42 | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 42 | 0 / 43 |
Outcome results
Primary
Anaerobic Bacteria
Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Flavor Option 1 | Anaerobic Bacteria | 8.40 colony forming units | Standard Deviation 0.33 |
| Total Flavor Option 2 | Anaerobic Bacteria | 8.42 colony forming units | Standard Deviation 0.25 |
| Crest Toothpaste | Anaerobic Bacteria | 8.43 colony forming units | Standard Deviation 0.28 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: >0.05ANOVA
Primary
Anaerobic Bacteria
Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.
Time frame: 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Flavor Option 1 | Anaerobic Bacteria | 7.68 colony forming units | Standard Error 0.09 |
| Total Flavor Option 2 | Anaerobic Bacteria | 7.71 colony forming units | Standard Error 0.09 |
| Crest Toothpaste | Anaerobic Bacteria | 8.37 colony forming units | Standard Error 0.09 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: <0.001ANCOVA
Primary
Malodor Bacteria (Breath Odor Causing Bacteria)
Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Flavor Option 1 | Malodor Bacteria (Breath Odor Causing Bacteria) | 6.26 colony forming units | Standard Deviation 0.44 |
| Total Flavor Option 2 | Malodor Bacteria (Breath Odor Causing Bacteria) | 6.26 colony forming units | Standard Deviation 0.5 |
| Crest Toothpaste | Malodor Bacteria (Breath Odor Causing Bacteria) | 6.40 colony forming units | Standard Deviation 0.46 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: >0.05ANOVA
Primary
Malodor Bacteria (Breath Odor Causing Bacteria)
Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.
Time frame: 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Flavor Option 1 | Malodor Bacteria (Breath Odor Causing Bacteria) | 5.99 colony forming units | Standard Error 0.07 |
| Total Flavor Option 2 | Malodor Bacteria (Breath Odor Causing Bacteria) | 5.92 colony forming units | Standard Error 0.07 |
| Crest Toothpaste | Malodor Bacteria (Breath Odor Causing Bacteria) | 6.32 colony forming units | Standard Error 0.07 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.002ANCOVA