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Trial record 10 of 43 for:    FLUORIDE ION AND TRICLOSAN

The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics

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ClinicalTrials.gov Identifier: NCT00763256
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : April 2, 2012
Last Update Posted : July 28, 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 Periodontal Disease
Interventions Drug: Triclosan, Fluoride
Drug: Fluoride
Enrollment 33
Recruitment Details all subjects were recruited at the clinical site by the PI.
Pre-assignment Details All subjects passed a medical exam and met the inclusion/exclusion criteria.
Arm/Group Title Active Comparator B - Placebo Comparator
Hide Arm/Group Description triclosan/fluoride/copolymer toothpaste fluoride only toothpaste
Period Title: Overall Study
Started 15 18
Completed 8 8
Not Completed 7 10
Reason Not Completed
Didn't return for appointments             7             10
Arm/Group Title Active Comparator B - Placebo Comparator Total
Hide Arm/Group Description triclosan/fluoride/copolymer toothpaste fluoride only toothpaste Total of all reporting groups
Overall Number of Baseline Participants 15 18 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 18 participants 33 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  93.3%
16
  88.9%
30
  90.9%
>=65 years
1
   6.7%
2
  11.1%
3
   9.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 18 participants 33 participants
53  (7.6) 49  (11) 51  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 18 participants 33 participants
Female
5
  33.3%
9
  50.0%
14
  42.4%
Male
10
  66.7%
9
  50.0%
19
  57.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 15 participants 18 participants 33 participants
15 18 33
1.Primary Outcome
Title HbA1c Levels in Blood
Hide Description Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator B - Placebo Comparator
Hide Arm/Group Description:
triclosan/fluoride/copolymer toothpaste
fluoride only toothpaste
Overall Number of Participants Analyzed 15 18
Mean (Standard Deviation)
Unit of Measure: Percentage
9.47  (2.2) 10.27  (2.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Comparator, B - 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 t-test, 2 sided
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. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator B - Placebo Comparator
Hide Arm/Group Description:
triclosan/fluoride/copolymer toothpaste
fluoride only toothpaste
Overall Number of Participants Analyzed 15 18
Mean (Standard Deviation)
Unit of Measure: mg/L
6.16  (5.5) 5.37  (3.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Comparator, B - 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 t-test, 2 sided
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. This peptide is usually found in equal levels to insulin. C-peptide levels measured as a means of distinguishing type 1 diabetes and type 2 diabetes. Blood is taken from each subject and C-Peptide levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator B - Placebo Comparator
Hide Arm/Group Description:
triclosan/fluoride/copolymer toothpaste
fluoride only toothpaste
Overall Number of Participants Analyzed 15 18
Mean (Standard Deviation)
Unit of Measure: nmol/L
1.20  (1.0) 1.04  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Comparator, B - 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 t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title Gingivitis Score (GI)
Hide Description

Units on a scale 0 to 3 (0 = no inflammation,

1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator B - Placebo Comparator
Hide Arm/Group Description:
triclosan/fluoride/copolymer toothpaste
fluoride only toothpaste
Overall Number of Participants Analyzed 15 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.89  (0.2) 0.88  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Comparator, B - 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 t-test, 2 sided
Comments [Not Specified]
5.Primary Outcome
Title P. Gingivalis
Hide Description Subgingival plaque samples were collected from all interproximal (mesial) sites and pooled prior to assessment. The samples will be analysed for the presence of P. gingivalis, using real time PCR to quantitate the numbers of bacteria. P. gingivalis is a non-motile, gram negative, anaerobic, pathogenic bacteria. It is linked to periodontal disease and causes collagen degradation.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator B - Placebo Comparator
Hide Arm/Group Description:
triclosan/fluoride/copolymer toothpaste
fluoride only toothpaste
Overall Number of Participants Analyzed 15 18
Median (Inter-Quartile Range)
Unit of Measure: Pg/ng DNA
209
(0 to 23688)
22
(0 to 15982)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Comparator, B - 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 t-test, 2 sided
Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Comparator B - Placebo Comparator
Hide Arm/Group Description triclosan/fluoride/copolymer toothpaste fluoride only toothpaste
All-Cause Mortality
Active Comparator B - Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Comparator B - Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (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 5%
Active Comparator B - Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (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, 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: NCT00763256     History of Changes
Other Study ID Numbers: 2004000841/2004/201
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: March 5, 2012
Results First Posted: April 2, 2012
Last Update Posted: July 28, 2015