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Compare the Clinical Efficacy of Prototype Toothpastes.

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ClinicalTrials.gov Identifier: NCT00761930
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : October 20, 2010
Last Update Posted : August 15, 2013
Sponsor:
Information provided by:
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Gingival Diseases
Interventions Drug: Fluoride
Drug: Triclosan and fluoride
Drug: Herbal Ingredient and fluoride
Enrollment 103
Recruitment Details subjects were recruited by the PI at the clinical site
Pre-assignment Details subjects were screened for meeting medical and oral health criteria. Then completed a 1 week washout period with fluoride toothpaste prior to receiving any study treatments.
Arm/Group Title A- Placebo Comparator B - Active Comparator C - Experimental Toothpaste
Hide Arm/Group Description Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste) fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste) fluoride/herbal toothpaste
Period Title: Overall Study
Started 34 34 35
Completed 34 34 35
Not Completed 0 0 0
Arm/Group Title A- Placebo Comparator B - Active Comparator C - Experimental Toothpaste Total
Hide Arm/Group Description Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste) fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste) fluoride/herbal toothpaste Total of all reporting groups
Overall Number of Baseline Participants 34 34 35 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 35 participants 103 participants
<=18 years
0
   0.0%
0
   0.0%
1
   2.9%
1
   1.0%
Between 18 and 65 years
34
 100.0%
34
 100.0%
34
  97.1%
102
  99.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 34 participants 35 participants 103 participants
40.3  (12.2) 42.68  (11.83) 40.8  (11.7) 41.3  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 35 participants 103 participants
Female
26
  76.5%
25
  73.5%
23
  65.7%
74
  71.8%
Male
8
  23.5%
9
  26.5%
12
  34.3%
29
  28.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 34 participants 35 participants 103 participants
34 34 35 103
1.Primary Outcome
Title Dental Plaque
Hide Description Quigley Hein Method: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score= sum of all scores divided by the number of sites (teeth) scored.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A- Placebo Comparator B - Active Comparator C - Experimental Toothpaste
Hide Arm/Group Description:
Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
fluoride/herbal toothpaste
Overall Number of Participants Analyzed 34 34 35
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.273  (0.328) 1.806  (0.523) 2.041  (0.403)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A- Placebo Comparator, B - Active Comparator, C - Experimental 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 ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Gingivitis Score
Hide Description

Gingivitis score (GI)= 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. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored.

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A- Placebo Comparator B - Active Comparator C - Experimental Toothpaste
Hide Arm/Group Description:
Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
fluoride/herbal toothpaste
Overall Number of Participants Analyzed 34 34 35
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.942  (0.302) 0.722  (0.369) 0.705  (0.387)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A- Placebo Comparator, B - Active Comparator, C - Experimental 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 ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Bleeding Index (EIBI)
Hide Description Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A- Placebo Comparator B - Active Comparator C - Experimental Toothpaste
Hide Arm/Group Description:
Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
fluoride/herbal toothpaste
Overall Number of Participants Analyzed 34 34 35
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.325  (.246) 0.164  (0.194) 0.141  (0.183)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A- Placebo Comparator, B - Active Comparator, C - Experimental 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 ANCOVA
Comments [Not Specified]
Time Frame 7 weeks (1 week washout period + 6 week study test period)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A- Placebo Comparator B - Active Comparator C - Experimental Toothpaste
Hide Arm/Group Description Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste) fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste) fluoride/herbal toothpaste
All-Cause Mortality
A- Placebo Comparator B - Active Comparator C - Experimental Toothpaste
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A- Placebo Comparator B - Active Comparator C - Experimental Toothpaste
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/34 (0.00%)   0/35 (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- Placebo Comparator B - Active Comparator C - Experimental Toothpaste
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/34 (0.00%)   0/35 (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: NCT00761930     History of Changes
Other Study ID Numbers: CRO-2007-GIN-04-RR
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: August 19, 2010
Results First Posted: October 20, 2010
Last Update Posted: August 15, 2013