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Trial record 18 of 43 for:    FLUORIDE ION AND TRICLOSAN

Evaluate Inflammation Caused by Gingivitis in Adults

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: NCT00941668
Recruitment Status : Completed
First Posted : July 17, 2009
Results First Posted : July 17, 2009
Last Update Posted : August 27, 2015
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: Treatment
Condition Gingivitis
Interventions Drug: Triclosan/Copolymer/fluoride toothpaste
Drug: sodium monofluorophosphate toothpaste
Enrollment 49
Recruitment Details subjects were recruited by the PI at the clinical site
Pre-assignment Details  
Arm/Group Title Total Toothpaste (Active) Colgate Great Regular Flavor (Placebo)
Hide Arm/Group Description triclosan/copolymer/fluoride toothpaste sodium monofluorophosphate toothpaste
Period Title: Overall Study
Started 24 25
Completed 0 0
Not Completed 24 25
Arm/Group Title Total Toothpaste (Active) Colgate Cavity Protection (Placebo) Total
Hide Arm/Group Description triclosan/copolymer/fluoride toothpaste sodium monofluorophosphate toothpaste Total of all reporting groups
Overall Number of Baseline Participants 24 25 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 49 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
 100.0%
25
 100.0%
49
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 25 participants 49 participants
39.9  (12.5) 34  (12.1) 36.25  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 49 participants
Female
12
  50.0%
12
  48.0%
24
  49.0%
Male
12
  50.0%
13
  52.0%
25
  51.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 25 participants 49 participants
24 25 49
1.Primary Outcome
Title Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours
Hide Description Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste (Active) Colgate Cavity Protection (Placebo)
Hide Arm/Group Description:
triclosan/copolymer/fluoride toothpaste
sodium monofluorophosphate toothpaste
Overall Number of Participants Analyzed 24 25
Mean (Standard Deviation)
Unit of Measure: Micrograms
492.2  (545.5) 326.3  (307.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste (Active), Colgate Cavity Protection (Placebo)
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 ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours
Hide Description Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste (Active) Colgate Cavity Protection (Placebo)
Hide Arm/Group Description:
triclosan/copolymer/fluoride toothpaste
sodium monofluorophosphate toothpaste
Overall Number of Participants Analyzed 24 25
Mean (Standard Deviation)
Unit of Measure: Micrograms
12.8  (23.3) 21.3  (46.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste (Active), Colgate Cavity Protection (Placebo)
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 ANCOVA
Comments [Not Specified]
Time Frame 29 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Total Toothpaste (Active) Colgate Cavity Protection (Placebo)
Hide Arm/Group Description triclosan/copolymer/fluoride toothpaste sodium monofluorophosphate toothpaste
All-Cause Mortality
Total Toothpaste (Active) Colgate Cavity Protection (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Total Toothpaste (Active) Colgate Cavity Protection (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/25 (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 Toothpaste (Active) Colgate Cavity Protection (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/24 (4.17%)      6/25 (24.00%)    
General disorders     
Tooth Sensitivity to Cold * [1]  1/24 (4.17%)  1 2/25 (8.00%)  2
Oral irritation * [2]  1/24 (4.17%)  1 1/25 (4.00%)  1
Cold and/or flu like symptoms * [3]  1/24 (4.17%)  1 2/25 (8.00%)  2
pulled muscle * [4]  1/24 (4.17%)  1 1/25 (4.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Subjects reported tooth sensitivity to cold
[2]
subject reported oral irritation after using the study product
[3]
2 subjects reported cold like symptoms halfway through the study and 1 subject reported flu like symptoms (Fever,chills and sore throat) at end of study.
[4]
1 subject reported a pulled muscle in their back at the end of the study
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: Willliam DeVizio-DMD
Organization: Colgate Palmolive
Phone: 732-878-7901
EMail: William_DeVizio@colpal.com
Layout table for additonal information
Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00941668     History of Changes
Other Study ID Numbers: CRO-1005-INF-UNC-FP
First Submitted: September 26, 2008
First Posted: July 17, 2009
Results First Submitted: September 26, 2008
Results First Posted: July 17, 2009
Last Update Posted: August 27, 2015