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Trial record 25 of 292 for:    Sodium Fluoride OR Duraphat

Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model

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ClinicalTrials.gov Identifier: NCT01799226
Recruitment Status : Completed
First Posted : February 26, 2013
Results First Posted : January 13, 2016
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Janet Kinney, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor)
Condition Gingivitis
Interventions Other: Toothpaste without triclosan
Other: Triclosan
Enrollment 32
Recruitment Details  
Pre-assignment Details

Initially 15 participants were sought for each arm, but when two were withdrawn from the control arm, two more participants were recruited and randomized, one to each arm. So total start on each arm was 16.

The Disqualification noted below for one participant was because s/he no longer met inclusion criteria as of day 14.

Arm/Group Title Control Arm Test Arm
Hide Arm/Group Description Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste). Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
Period Title: Overall Study
Started 16 16
Right Stent Side 8 8
Left Stent Side 8 8
Completed 14 16
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             1             0
Disqualified at Day 14             1             0
Arm/Group Title Control Arm Test Arm Total
Hide Arm/Group Description Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste). Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste). Total of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Age Number Analyzed 16 participants 16 participants 32 participants
27.07
(21.92 to 32.32)
26.06
(20.83 to 31.29)
26.57
(20.83 to 32.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Female
14
  87.5%
9
  56.3%
23
  71.9%
Male
2
  12.5%
7
  43.8%
9
  28.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Hispanic or Latino
1
   6.3%
1
   6.3%
2
   6.3%
Not Hispanic or Latino
13
  81.3%
15
  93.8%
28
  87.5%
Unknown or Not Reported
2
  12.5%
0
   0.0%
2
   6.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  12.5%
2
  12.5%
4
  12.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   6.3%
1
   6.3%
2
   6.3%
White
9
  56.3%
11
  68.8%
20
  62.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
  25.0%
2
  12.5%
6
  18.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 16 participants 32 participants
16 16 32
Bleeding on probing ≤ 10%  
Mean (Full Range)
Unit of measure:  Percent of sites bleeding on probing
Number Analyzed 16 participants 16 participants 32 participants
0.065
(0.02 to 0.10)
0.063
(0.02 to 0.10)
0.064
(0.02 to 0.10)
1.Primary Outcome
Title Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35
Hide Description Silness & Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35.
Time Frame Baseline to 35 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
Arm/Group Title Control Arm Test Arm
Hide Arm/Group Description:
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
Overall Number of Participants Analyzed 14 16
Mean (Standard Error)
Unit of Measure: units on a scale
Plaque index Baseline 0.37  (0.06) 0.44  (0.07)
Plaque index Day 14 1.24  (0.07) 1.49  (0.08)
Plaque index Day 21 1.84  (0.10) 1.81  (0.10)
Plaque index Day 35 0.45  (0.06) 0.57  (0.04)
2.Secondary Outcome
Title Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35
Hide Description Loe & Silness 1963 is a score of 0-3 with 0 = Absence of inflammation, 1 = Mild inflammation, slight change in color and texture, 2 = Moderate inflammation, glazing, redness, edema and hypertrophy, 3 = Severe inflammation, redness and hypertrophy, ulceration. This index was used at days 0, 14, 21 and 35.
Time Frame Baseline to 35 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
Arm/Group Title Control Arm Test Arm
Hide Arm/Group Description:
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
Overall Number of Participants Analyzed 14 16
Mean (Standard Error)
Unit of Measure: units on a scale
Gingival index Baseline 0.25  (0.04) 0.32  (0.03)
Gingival index Day 14 1.33  (0.06) 1.38  (0.07)
Gingival index Day 21 1.56  (0.07) 1.52  (0.07)
Gingival index Day 35 0.39  (0.07) 0.47  (0.07)
3.Other Pre-specified Outcome
Title Unstimulated Whole Saliva Will be Collected for Inflammatory Biomarker Expression.
Hide Description Inflammatory biomarker expression will be quantified using a custom human 10-complex protein array that is optimized for sensitivity, specificity, stability, and intraassay coefficient of variation by comparing to single cytokine enzyme-linked immunosorbent assays (Quantibody Custom Array, RayBiotech, Norcross, GA).
Time Frame Baseline to 35 Days
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Plaque Samples Will be Collected for Bacterial Species Detection.
Hide Description Supra- and sub-gingival plaque samples will be gently collected using a sterile curet and a one stroke method from two randomized sites within the stent area. The detection of 40 bacterial species will be evaluated by the checkerboard DNA-DNA hybridization technique originally described by Socransky et al. 1994.
Time Frame Baseline to 35 Days
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Gingival Crevicular Fluid (GCF) Will be Collected for Inflammatory Biomarker Expression.
Hide Description A total of 10 biomarkers will be analyzed based on the results from Lee and colleagues: IL-1α, IL-1β, IL-6, IL-8, IL-10, MCP-1, MMP-8, MMP-9, TIMP-1, and TIMP-2.
Time Frame Baseline to 35 Days
Outcome Measure Data Not Reported
Time Frame All adverse event data was collected for 9 months.
Adverse Event Reporting Description Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
 
Arm/Group Title Control Arm Test Arm
Hide Arm/Group Description Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste). Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
All-Cause Mortality
Control Arm Test Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control Arm Test Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control Arm Test Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/16 (25.00%)      8/16 (50.00%)    
General disorders     
Aphthous ulcer *  1/16 (6.25%)  1 3/16 (18.75%)  3
Tissue slough *  2/16 (12.50%)  2 0/16 (0.00%)  0
TMJ soreness *  0/16 (0.00%)  0 1/16 (6.25%)  1
Tooth decay *  1/16 (6.25%)  1 0/16 (0.00%)  0
Tingling in tongue *  0/16 (0.00%)  0 1/16 (6.25%)  1
Toothbrush trauma *  0/16 (0.00%)  0 1/16 (6.25%)  1
Herpetic lesion *  0/16 (0.00%)  0 2/16 (12.50%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Janet Kinney
Organization: UMichigan
Phone: 734-615-5452
EMail: kinneyj@umich.edu
Layout table for additonal information
Responsible Party: Janet Kinney, University of Michigan
ClinicalTrials.gov Identifier: NCT01799226     History of Changes
Other Study ID Numbers: HUM00055445
First Submitted: February 24, 2013
First Posted: February 26, 2013
Results First Submitted: July 23, 2015
Results First Posted: January 13, 2016
Last Update Posted: January 13, 2016