Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 87 of 295 for:    Sodium Fluoride OR Duraphat

Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02194621
Recruitment Status : Completed
First Posted : July 18, 2014
Results First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Oral Bacteria Levels in the Mouth
Interventions Drug: Total Flavor option 1
Drug: Total Flavor option 2
Drug: Placebo toothpaste: Crest Cavity Protection toothpaste
Enrollment 128
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.
Arm/Group Title Total Flavor Option 1 Total Flavor Option 2 Crest Toothpaste
Hide Arm/Group Description

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 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

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)

Period Title: Overall Study
Started 43 42 43
Completed 37 36 34
Not Completed 6 6 9
Reason Not Completed
6 withdrew prior to randomization             2             2             2
Withdrawal by Subject             4             4             7
Arm/Group Title Total Flavor Option 1 Total Flavor Option 2 Crest Toothpaste Total
Hide Arm/Group Description

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 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

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 of all reporting groups
Overall Number of Baseline Participants 43 42 43 128
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 42 participants 43 participants 128 participants
36.6  (10.2) 34.2  (10.34) 35.9  (12.08) 35.4  (10.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 43 participants 128 participants
Female
28
  65.1%
29
  69.0%
24
  55.8%
81
  63.3%
Male
15
  34.9%
13
  31.0%
19
  44.2%
47
  36.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants 42 participants 43 participants 128 participants
43 42 43 128
1.Primary Outcome
Title Anaerobic Bacteria
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Flavor Option 1 Total Flavor Option 2 Crest Toothpaste
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 43 42 43
Mean (Standard Deviation)
Unit of Measure: colony forming units
8.40  (0.33) 8.42  (0.25) 8.43  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Flavor Option 1, Total Flavor Option 2, Crest Toothpaste
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Anaerobic Bacteria
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Flavor Option 1 Total Flavor Option 2 Crest Toothpaste
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 37 36 34
Mean (Standard Error)
Unit of Measure: colony forming units
7.68  (0.09) 7.71  (0.09) 8.37  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Flavor Option 2, Crest Toothpaste
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Malodor Bacteria (Breath Odor Causing Bacteria)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Flavor Option 1 Total Flavor Option 2 Crest Toothpaste
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 37 36 34
Mean (Standard Deviation)
Unit of Measure: colony forming units
6.26  (0.44) 6.26  (0.50) 6.40  (0.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Flavor Option 1, Total Flavor Option 2, Crest Toothpaste
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Primary Outcome
Title Malodor Bacteria (Breath Odor Causing Bacteria)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Flavor Option 1 Total Flavor Option 2 Crest Toothpaste
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 37 36 34
Mean (Standard Error)
Unit of Measure: colony forming units
5.99  (0.07) 5.92  (0.07) 6.32  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Flavor Option 1, Total Flavor Option 2, Crest Toothpaste
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Baseline, 12 hours and 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Total Flavor Option 1 Total Flavor Option 2 Crest Toothpaste
Hide Arm/Group Description

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 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

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)

All-Cause Mortality
Total Flavor Option 1 Total Flavor Option 2 Crest Toothpaste
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Total Flavor Option 1 Total Flavor Option 2 Crest Toothpaste
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/42 (0.00%)   0/43 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Total Flavor Option 1 Total Flavor Option 2 Crest Toothpaste
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/42 (0.00%)   0/43 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Daniel Fine, DMD
Organization: RBHS-Rutgers School of Dental Medicine, Oral Biology Department
Phone: 973-972-3728
EMail: finedh@sdm.rutgers.edu
Layout table for additonal information
Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT02194621     History of Changes
Other Study ID Numbers: CRO-1113-BACT-PS-NJ
First Submitted: July 15, 2014
First Posted: July 18, 2014
Results First Submitted: February 1, 2016
Results First Posted: April 15, 2016
Last Update Posted: April 15, 2016