Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 43 for:    FLUORIDE ION AND TRICLOSAN

Investigate Plaque and Gingival Index

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: NCT00762762
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : April 26, 2012
Last Update Posted : April 26, 2012
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Periodontitis
Interventions Drug: Triclosan and fluoride
Drug: Fluoride
Enrollment 46
Recruitment Details all subjects were recruited by the PI at the clinical site.
Pre-assignment Details all subjects pass a medical exam and meet the study inclusion/exclusion criteria.
Arm/Group Title Active Comparator Placebo Comparator
Hide Arm/Group Description triclosan/fluoride/copolymer toothpaste Anti-cavity, fluoride oral rinse
Period Title: Overall Study
Started 30 30
Completed 22 20
Not Completed 8 10
Reason Not Completed
Did not report for appointments             8             10
Arm/Group Title Active Comparator Placebo Comparator Total
Hide Arm/Group Description triclosan/fluoride/copolymer toothpaste Anti-cavity, fluoride oral rinse Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
30
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
50.6  (7.5) 48.8  (8.7) 49.7  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
13
  43.3%
13
  43.3%
26
  43.3%
Male
17
  56.7%
17
  56.7%
34
  56.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title HbA1c Levels in Blood
Hide Description Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator Placebo Comparator
Hide Arm/Group Description:
triclosan/fluoride/copolymer toothpaste
Anti-cavity, fluoride oral rinse
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: percentage of HbA1c levels
11.42  (1.71) 10.81  (1.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Comparator, Placebo 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 ANOVA
Comments [Not Specified]
2.Primary Outcome
Title High Sensitivity CRP (C-Reactive Protein)
Hide Description CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator Placebo Comparator
Hide Arm/Group Description:
triclosan/fluoride/copolymer toothpaste
Anti-cavity, fluoride oral rinse
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: µg/ml
14.94  (13.62) 10.76  (8.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Comparator, Placebo 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 ANOVA
Comments [Not Specified]
3.Primary Outcome
Title C-Peptide
Hide Description C-Peptide levels in blood indicate whether or not a person is producing insulin
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator Placebo Comparator
Hide Arm/Group Description:
triclosan/fluoride/copolymer toothpaste
Anti-cavity, fluoride oral rinse
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: ng/ml
5.39  (3.68) 4.61  (2.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Comparator, Placebo 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 ANOVA
Comments [Not Specified]
4.Primary Outcome
Title IL-6 (Interleukin - 6)
Hide Description Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picagrams)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator Placebo Comparator
Hide Arm/Group Description:
triclosan/fluoride/copolymer toothpaste
Anti-cavity, fluoride oral rinse
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: pg/ml
1.93  (1.44) 2.89  (3.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Comparator, Placebo 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 ANOVA
Comments [Not Specified]
5.Primary Outcome
Title TNF-α (Tumor Necrosis Factor - Alpha)
Hide Description Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator Placebo Comparator
Hide Arm/Group Description:
triclosan/fluoride/copolymer toothpaste
Anti-cavity, fluoride oral rinse
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: pg/ml
4.13  (4.84) 3.50  (6.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Comparator, Placebo 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 ANOVA
Comments [Not Specified]
Time Frame 24 months (2 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Comparator Placebo Comparator
Hide Arm/Group Description triclosan/fluoride/copolymer toothpaste Anti-cavity, fluoride oral rinse
All-Cause Mortality
Active Comparator Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Comparator Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Comparator Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (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, DMD
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: NCT00762762     History of Changes
Other Study ID Numbers: 2004000685
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: April 2, 2012
Results First Posted: April 26, 2012
Last Update Posted: April 26, 2012