A Phase 4 interventional study of Total Flavor option 1 and Total Flavor option 2 in Oral Bacteria Levels in the Mouth, sponsored by Colgate Palmolive. Completed at 1 site in United States. Open to participants aged 22 Years to 58 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-15.
Sponsored by Colgate Palmolive · Phase 4, Interventional, and Prevention
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.
Colgate Palmolive is the lead sponsor of 114 studies on the registry; 12 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 1 ingredient - Total Flavor Option 1
Drug: Total Flavor option 1
Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 2 ingredient. Total Flavor Option 2
Drug: Total Flavor option 2
Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)
Drug: Placebo toothpaste: Crest Cavity Protection toothpaste
Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1
Also known as: Total toothpaste
Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2
Also known as: Total toothpaste
Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)
Also known as: Crest Anti-Cavity toothpaste
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
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
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
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
subject recruitment is completed locally at the clinical site
| Milestone | Total Flavor Option 1 | Total Flavor Option 2 | Crest Toothpaste |
|---|---|---|---|
| Started | 43 | 42 | 43 |
| Completed | 37 | 36 | 34 |
| Not completed | 6 | 6 | 9 |
| Withdrew: 6 withdrew prior to randomization | 2 | 2 | 2 |
| Withdrew: Withdrawal by subject | 4 | 4 | 7 |
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.
| colony forming units | Total Flavor Option 1 | Total Flavor Option 2 | Crest Toothpaste |
|---|---|---|---|
| Anaerobic Bacteria | 8.40 ± 0.33 | 8.42 ± 0.25 | 8.43 ± 0.28 |
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.
| colony forming units | Total Flavor Option 1 | Total Flavor Option 2 | Crest Toothpaste |
|---|---|---|---|
| Anaerobic Bacteria | 7.68 ± 0.09 | 7.71 ± 0.09 | 8.37 ± 0.09 |
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.
| colony forming units | Total Flavor Option 1 | Total Flavor Option 2 | Crest Toothpaste |
|---|---|---|---|
| Malodor Bacteria (Breath Odor Causing Bacteria) | 6.26 ± 0.44 | 6.26 ± 0.50 | 6.40 ± 0.46 |
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.
| colony forming units | Total Flavor Option 1 | Total Flavor Option 2 | Crest Toothpaste |
|---|---|---|---|
| Malodor Bacteria (Breath Odor Causing Bacteria) | 5.99 ± 0.07 | 5.92 ± 0.07 | 6.32 ± 0.07 |
Collected over Baseline, 12 hours and 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total Flavor Option 1 | — | 0/43 (0%) | 0/43 (0%) |
| Total Flavor Option 2 | — | 0/42 (0%) | 0/42 (0%) |
| Crest Toothpaste | — | 0/43 (0%) | 0/43 (0%) |
| Age, Continuous(years) | Total Flavor Option 1 | Total Flavor Option 2 | Crest Toothpaste | Total |
|---|---|---|---|---|
| Mean | 36.6 ± 10.2 | 34.2 ± 10.34 | 35.9 ± 12.08 | 35.4 ± 10.82 |
| Sex: Female, Male(Participants) | Total Flavor Option 1 | Total Flavor Option 2 | Crest Toothpaste | Total |
|---|---|---|---|---|
| Female | 28 | 29 | 24 | 81 |
| Male | 15 | 13 | 19 | 47 |
| Region of Enrollment(participants) | Total Flavor Option 1 | Total Flavor Option 2 | Crest Toothpaste | Total |
|---|---|---|---|---|
| United States | 43 | 42 | 43 | 128 |
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Colgate Palmolive