Trial Outcomes & Findings for Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria (NCT NCT02194621)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

128 participants

Primary outcome timeframe

Baseline

Results posted on

2016-04-15

Participant Flow

subject recruitment is completed locally at the clinical site

There will be a one (1) week wash out phase with commercially available fluoride toothpaste prior to any study intervention being assigned.

Participant milestones

Participant milestones
Measure	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	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	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)
Overall Study STARTED	43	42	43
Overall Study COMPLETED	37	36	34
Overall Study NOT COMPLETED	6	6	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	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)
Overall Study 6 withdrew prior to randomization	2	2	2
Overall Study Withdrawal by Subject	4	4	7

Baseline Characteristics

Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Flavor Option 1 n=43 Participants 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	Total Flavor Option 2 n=42 Participants 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	Crest Toothpaste n=43 Participants 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)	Total n=128 Participants Total of all reporting groups
Age, Continuous	36.6 years STANDARD_DEVIATION 10.2 • n=5 Participants	34.2 years STANDARD_DEVIATION 10.34 • n=7 Participants	35.9 years STANDARD_DEVIATION 12.08 • n=5 Participants	35.4 years STANDARD_DEVIATION 10.82 • n=4 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	29 Participants n=7 Participants	24 Participants n=5 Participants	81 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants	47 Participants n=4 Participants
Region of Enrollment United States	43 participants n=5 Participants	42 participants n=7 Participants	43 participants n=5 Participants	128 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Total Flavor Option 1 n=43 Participants 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	Total Flavor Option 2 n=42 Participants 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	Crest Toothpaste n=43 Participants 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)
Anaerobic Bacteria	8.40 colony forming units Standard Deviation 0.33	8.42 colony forming units Standard Deviation 0.25	8.43 colony forming units Standard Deviation 0.28

PRIMARY outcome

Timeframe: 12 hours

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.

Outcome measures

Outcome measures
Measure	Total Flavor Option 1 n=37 Participants 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	Total Flavor Option 2 n=36 Participants 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	Crest Toothpaste n=34 Participants 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)
Anaerobic Bacteria	7.68 colony forming units Standard Error 0.09	7.71 colony forming units Standard Error 0.09	8.37 colony forming units Standard Error 0.09

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Total Flavor Option 1 n=37 Participants 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	Total Flavor Option 2 n=36 Participants 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	Crest Toothpaste n=34 Participants 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)
Malodor Bacteria (Breath Odor Causing Bacteria)	6.26 colony forming units Standard Deviation 0.44	6.26 colony forming units Standard Deviation 0.50	6.40 colony forming units Standard Deviation 0.46

PRIMARY outcome

Timeframe: 12 hours

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.

Outcome measures

Outcome measures
Measure	Total Flavor Option 1 n=37 Participants 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	Total Flavor Option 2 n=36 Participants 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	Crest Toothpaste n=34 Participants 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)
Malodor Bacteria (Breath Odor Causing Bacteria)	5.99 colony forming units Standard Error 0.07	5.92 colony forming units Standard Error 0.07	6.32 colony forming units Standard Error 0.07

Adverse Events

Total Flavor Option 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Total Flavor Option 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Crest Toothpaste

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Fine, DMD

RBHS-Rutgers School of Dental Medicine, Oral Biology Department

Phone: 973-972-3728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60