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Trial record 14 of 43 for:    FLUORIDE ION AND TRICLOSAN

Effect on Bacterial Glycolytic Acid Formation on Plaque

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: NCT00762450
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : February 15, 2011
Last Update Posted : March 7, 2012
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dental Plaque
Interventions Drug: Triclosan, Fluoride
Drug: fluoride
Drug: Fluoride, triclosan, amino acid
Enrollment 6
Recruitment Details subjects are recruited by the PI at the clinical site
Pre-assignment Details subjects are screened for medical and oral health criteria and start a 1 week washout period.
Arm/Group Title Placebo 1st, Active Comparator 2nd and Experimental Last Active Comparator 1st, Experimental 2nd and Placebo Last Experimental 1st, Placebo 2nd and Active Comparator Last
Hide Arm/Group Description Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days. Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days. Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
Period Title: 1st Treatment Period
Started 2 2 2
Completed 2 2 2
Not Completed 0 0 0
Period Title: Washout After 1st Treatment Period
Started 2 2 2
Completed 2 2 2
Not Completed 0 0 0
Period Title: 2nd Treatment Period
Started 2 2 2
Completed 2 2 2
Not Completed 0 0 0
Period Title: Washout After 2nd Treatment Period
Started 2 2 2
Completed 2 2 2
Not Completed 0 0 0
Period Title: 3rd Treatment Period
Started 2 2 2
Completed 2 2 2
Not Completed 0 0 0
Arm/Group Title Placebo First, Positive Control Second and Experimental Last Positive Control First, Experimental Second and Placebo Last Experimental First, Placebo Second and Positive Control Last Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 2 2 2 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 2 participants 6 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
2
 100.0%
2
 100.0%
2
 100.0%
6
 100.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 2 participants 6 participants
76.5  (3.5) 77.5  (0.7) 73.5  (2.1) 75.8  (2.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 2 participants 6 participants
Female
1
  50.0%
2
 100.0%
1
  50.0%
4
  66.7%
Male
1
  50.0%
0
   0.0%
1
  50.0%
2
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Switzerland Number Analyzed 2 participants 2 participants 2 participants 6 participants
2 2 2 6
1.Primary Outcome
Title ph of Dental Plaque After Sucrose Challenge
Hide Description Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator Placebo - Silica Control Experimental Toothpaste
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 6 6 6
Mean (Standard Deviation)
Unit of Measure: ph of dental plaque
4.88  (0.38) 5.04  (0.38) 4.98  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Comparator, Placebo - Silica Control, Experimental 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 paired t-tests
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo First, Positive Control Second and Experimental Last Positive Control First, Experimental Second and Placebo Last Experimental First, Placebo Second and Positive Control Last
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Placebo First, Positive Control Second and Experimental Last Positive Control First, Experimental Second and Placebo Last Experimental First, Placebo Second and Positive Control Last
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo First, Positive Control Second and Experimental Last Positive Control First, Experimental Second and Placebo Last Experimental First, Placebo Second and Positive Control Last
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo First, Positive Control Second and Experimental Last Positive Control First, Experimental Second and Placebo Last Experimental First, Placebo Second and Positive Control Last
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%)   0/2 (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: William De Vizio
Organization: Colgate Palmolive Co.
Phone: 732-878-7901
EMail: William_Devizio@colpal.com
Layout table for additonal information
Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00762450     History of Changes
Other Study ID Numbers: CRO-2008-PLA-01-AM
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: December 14, 2010
Results First Posted: February 15, 2011
Last Update Posted: March 7, 2012