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Trial record 7 of 43 for:    FLUORIDE ION AND TRICLOSAN

Compare Anti-inflammatory Dentifrices

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ClinicalTrials.gov Identifier: NCT00762528
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : April 3, 2012
Last Update Posted : September 10, 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 subject recruitment will be completed by the PI at the clinical site.
Pre-assignment Details Subjects are screened for plaque, bleeding and gingivitis scores before being assigned to any Study Treatment. Study Treatment randomization is balanced across the two treatment groups and is accomplished by stratification of subjects by gender (male & female) and baseline gingivitis (GI) scores.
Arm/Group Title Total Toothpaste Fluoride Toothpaste
Hide Arm/Group Description Triclosan/Copolymer/fluoride toothpaste Sodium monofluorophosphate toothpaste
Period Title: Overall Study
Started 24 25
Completed 24 25
Not Completed 0 0
Arm/Group Title Total Toothpaste Fluoride Toothpaste 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
27.5  (10.7) 29.2  (9.6) 28.4  (10.1)
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 Gingival Index (GI)
Hide Description

Gingival Index(GI)recorded on scale of 0-3 detailed below:

0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration & tendency to spontaneously bleed

Time Frame 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Fluoride Toothpaste
Hide Arm/Group Description:
Triclosan/Copolymer/fluoride toothpaste
sodium monofluorophosphate toothpaste
Overall Number of Participants Analyzed 24 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.04  (0.22) 1.01  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Fluoride 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 Prostaglandin E2 (PGE2)
Hide Description Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Time Frame 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Fluoride Toothpaste
Hide Arm/Group Description:
Triclosan/Copolymer/fluoride toothpaste
sodium monofluorophosphate toothpaste
Overall Number of Participants Analyzed 24 25
Log Mean (Standard Deviation)
Unit of Measure: pg/µl
5.8  (2.7) 5.2  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Fluoride 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]
3.Primary Outcome
Title Interleukin - 1 Beta (IL-ß)
Hide Description Inflammatory biomarkers found in gingival crevicular fluid (GCF) that may be a factor in oral tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Time Frame 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Fluoride Toothpaste
Hide Arm/Group Description:
Triclosan/Copolymer/fluoride toothpaste
sodium monofluorophosphate toothpaste
Overall Number of Participants Analyzed 24 25
Log Mean (Standard Deviation)
Unit of Measure: pg/µl
6.9  (0.8) 6.6  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Fluoride 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 Interleukin-6 (IL-6)
Hide Description Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Time Frame 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Fluoride Toothpaste
Hide Arm/Group Description:
Triclosan/Copolymer/fluoride toothpaste
sodium monofluorophosphate toothpaste
Overall Number of Participants Analyzed 24 25
Log Mean (Standard Deviation)
Unit of Measure: pg/µl
2.8  (0.7) 2.7  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Fluoride 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]
5.Primary Outcome
Title Nuclear Factor Kappa B Ligand (RANK-L)
Hide Description Receptor activator found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Time Frame 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Fluoride Toothpaste
Hide Arm/Group Description:
Triclosan/Copolymer/fluoride toothpaste
sodium monofluorophosphate toothpaste
Overall Number of Participants Analyzed 24 25
Log Mean (Standard Deviation)
Unit of Measure: pg/µl
4.5  (0.9) 4.4  (1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Fluoride 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]
6.Primary Outcome
Title 8-iso-prostaglandinF2α (8-iso-PGF2α)
Hide Description Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Time Frame 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Fluoride Toothpaste
Hide Arm/Group Description:
Triclosan/Copolymer/fluoride toothpaste
sodium monofluorophosphate toothpaste
Overall Number of Participants Analyzed 24 25
Log Mean (Standard Deviation)
Unit of Measure: pg/µl
14.2  (3.8) 15.2  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Fluoride 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]
7.Secondary Outcome
Title Dental Plaque Index (PI)
Hide Description measurement of supragingival dental plaque on scale of 0-3. 0=No plaque in gingival area,1=a film of plaque adhering to the free gingival margin and the adjacent tooth,2=Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth-visible by the naked eye, 3=Abundance of soft matter within the gingival pocket and/or gingival margin and adjacent tooth surfaces.
Time Frame 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Fluoride Toothpaste
Hide Arm/Group Description:
Triclosan/Copolymer/fluoride toothpaste
sodium monofluorophosphate toothpaste
Overall Number of Participants Analyzed 24 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.69  (0.30) 1.65  (0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Fluoride 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]
8.Secondary Outcome
Title Bleeding on Probing (BOP)
Hide Description Presence or absence of bleeding to manual probing as a dichotomous variable as follows: 0 = No bleeding within 10 seconds after probing, 1 = Bleeding within 10 seconds after probing.
Time Frame 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Fluoride Toothpaste
Hide Arm/Group Description:
Triclosan/Copolymer/fluoride toothpaste
sodium monofluorophosphate toothpaste
Overall Number of Participants Analyzed 24 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.24  (0.10) 0.26  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Fluoride 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]
Time Frame 29 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Total Toothpaste Fluoride Toothpaste
Hide Arm/Group Description Triclosan/Copolymer/fluoride toothpaste sodium monofluorophosphate toothpaste
All-Cause Mortality
Total Toothpaste Fluoride Toothpaste
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Total Toothpaste Fluoride Toothpaste
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 Fluoride Toothpaste
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/24 (4.17%)      6/25 (24.00%)    
General disorders     
Teeth Sensitive to cold * [1]  0/24 (0.00%)  0 2/25 (8.00%)  2
Oral Irritation * [2]  0/24 (0.00%)  0 1/25 (4.00%)  1
chest cold, upper respiratory infection * [3]  1/24 (4.17%)  1 1/25 (4.00%)  1
Pulled muscle in back * [4]  0/24 (0.00%)  0 1/25 (4.00%)  1
Fever, chills & sore throat * [5]  0/24 (0.00%)  0 1/25 (4.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
2 subjects reported tooth sensitivity to cold.
[2]
subject reported oral irritation
[3]
2 subjects reported having a cold
[4]
subject reported having a pulled muscle in their back.
[5]
subject reported experiencing a fever, chills and sore throat.
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, DMD
Organization: Colgate Palmolive Company
Phone: 732-878-7901
EMail: william_Devizio@colpal.com
Layout table for additonal information
Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00762528     History of Changes
Other Study ID Numbers: CRO-1107-INF-ECU-FP
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: March 5, 2012
Results First Posted: April 3, 2012
Last Update Posted: September 10, 2015