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Trial record 19 of 43 for:    FLUORIDE ION AND TRICLOSAN

Collection of Gingival Crevicular Fluid From Periodontitis Patients

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: NCT00763048
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : March 1, 2011
Last Update Posted : June 14, 2011
Sponsor:
Information provided by:
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Gingival Diseases
Interventions Drug: Fluoride
Drug: Fluoride, triclosan
Enrollment 39
Recruitment Details subjects were recruited by the PI at the clinical site
Pre-assignment Details Subjects were screened to meet medical and oral health criteria and then began a 1 week washout period with fluoride toothpaste.
Arm/Group Title A - Control Comparator B - Active Comparator
Hide Arm/Group Description Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks. Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Period Title: Overall Study
Started 21 18
Completed 21 18
Not Completed 0 0
Arm/Group Title A - Control Comparator B - Active Comparator Total
Hide Arm/Group Description Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks. Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks. Total of all reporting groups
Overall Number of Baseline Participants 21 18 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 18 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
18
 100.0%
39
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 18 participants 39 participants
48  (12.7) 49.8  (12.8) 48.9  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 18 participants 39 participants
Female
10
  47.6%
6
  33.3%
16
  41.0%
Male
11
  52.4%
12
  66.7%
23
  59.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 18 participants 39 participants
21 18 39
1.Primary Outcome
Title Metabolite Associated With Inflammation (Cadaverine)
Hide Description One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Control Comparator B - Active Comparator
Hide Arm/Group Description:
Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: ion count
1.119186  (0.834969) 0.92077  (0.78476)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Control Comparator, B - Active Comparator
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 t-test, 1 sided
Comments [Not Specified]
2.Primary Outcome
Title Metabolite Associated With Inflammation (Choline)
Hide Description One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Control Comparator B - Active Comparator
Hide Arm/Group Description:
Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: ion count
1.2264  (0.79066) 1.169513  (0.79071)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Control Comparator, B - Active Comparator
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 t-test, 1 sided
Comments [Not Specified]
3.Primary Outcome
Title Metabolite Associated With Inflammation (Hypoxanthine)
Hide Description One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Control Comparator B - Active Comparator
Hide Arm/Group Description:
Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: ion count
0.76984  (0.58459) 0.701628  (0.63887)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Control Comparator, B - Active Comparator
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 t-test, 1 sided
Comments [Not Specified]
4.Primary Outcome
Title Metabolite Associated With Inflammation (Inosine)
Hide Description One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Control Comparator B - Active Comparator
Hide Arm/Group Description:
Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: ion count
1.11183  (1.05685) 0.84462  (0.99409)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Control Comparator, B - Active Comparator
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 t-test, 1 sided
Comments [Not Specified]
5.Primary Outcome
Title Metabolite Associated With Inflammation (Isoleucine)
Hide Description One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Control Comparator B - Active Comparator
Hide Arm/Group Description:
Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: ion count
1.20033  (0.61108) 1.048449  (0.70947)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Control Comparator, B - Active Comparator
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 t-test, 1 sided
Comments [Not Specified]
6.Primary Outcome
Title Metabolite Associated With Inflammation (Leucine)
Hide Description One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Control Comparator B - Active Comparator
Hide Arm/Group Description:
Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: ion count
1.10064  (0.5424) 1.018989  (0.64132)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Control Comparator, B - Active Comparator
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 t-test, 1 sided
Comments [Not Specified]
7.Primary Outcome
Title Metabolite Associated With Inflammation (Lysine)
Hide Description One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Control Comparator B - Active Comparator
Hide Arm/Group Description:
Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: ion count
1.063873  (0.785917) 1.09704  (1.149168)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Control Comparator, B - Active Comparator
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 t-test, 1 sided
Comments [Not Specified]
8.Primary Outcome
Title Metabolite Associated With Inflammation (Phenylalanine)
Hide Description One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Control Comparator B - Active Comparator
Hide Arm/Group Description:
Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: ion count
1.16994  (0.56433) 1.057373  (0.625110)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Control Comparator, B - Active Comparator
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 t-test, 1 sided
Comments [Not Specified]
9.Primary Outcome
Title Metabolite Associated With Inflammation (Putrescine)
Hide Description One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Control Comparator B - Active Comparator
Hide Arm/Group Description:
Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: ion count
1.050398  (0.69913) 0.74134  (0.86837)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Control Comparator, B - Active Comparator
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 t-test, 1 sided
Comments [Not Specified]
10.Primary Outcome
Title Metabolite Associated With Inflammation (Xanthine)
Hide Description One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present.Data is after 6 weeks use of the study treatment.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Control Comparator B - Active Comparator
Hide Arm/Group Description:
Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: ion count
1.05189  (0.615226) 1.011732  (0.96834)
Time Frame 7 weeks (1 week washout period + 6 week study treatment period)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A - Control Comparator B - Active Comparator
Hide Arm/Group Description Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks. Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
All-Cause Mortality
A - Control Comparator B - Active Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A - Control Comparator B - Active Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A - Control Comparator B - Active Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/18 (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 Devizio
Organization: Colgate Palmolive Co.
Phone: 732-878-7901
EMail: William_Devizio@colpal.com
Layout table for additonal information
Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00763048     History of Changes
Other Study ID Numbers: CRO-2007-GIN-05-GB
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: August 19, 2010
Results First Posted: March 1, 2011
Last Update Posted: June 14, 2011