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Compare the Clinical Efficacy of Prototype Toothpastes

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ClinicalTrials.gov Identifier: NCT00926029
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : June 23, 2009
Last Update Posted : February 17, 2012
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 Dental Plaque
Interventions Drug: Fluoride
Drug: Triclosan, fluoride
Other: Metal salt
Enrollment 98
Recruitment Details At the clinical site
Pre-assignment Details  
Arm/Group Title Placebo Control Positive Control Experimental
Hide Arm/Group Description fluoride toothpaste (Winterfresh Gel) triclosan/fluoride toothpaste triclosan/fluoride/metal salt toothpaste
Period Title: Overall Study
Started 34 34 34
Completed 32 33 33
Not Completed 2 1 1
Reason Not Completed
Lost to Follow-up             2             1             1
Arm/Group Title Placebo Control Positive Control Experimental Total
Hide Arm/Group Description fluoride toothpaste triclosan/fluoride toothpaste triclosan/fluoride/zinc toothpaste Total of all reporting groups
Overall Number of Baseline Participants 34 34 34 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 34 participants 102 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0.0
Between 18 and 65 years
34
 100.0%
34
 100.0%
34
 100.0%
102.0
>=65 years
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 34 participants 102 participants
46.7  (11.2) 46.4  (10.5) 48.9  (9.5) 47.4  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 34 participants 102 participants
Female
25
  73.5%
26
  76.5%
29
  85.3%
80.0
Male
9
  26.5%
8
  23.5%
5
  14.7%
22.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 34 participants 34 participants 102 participants
34 34 34 102
1.Primary Outcome
Title Plaque Index
Hide Description Plaque Index score 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)
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Control Positive Control Experimental
Hide Arm/Group Description:
fluoride toothpaste (Winterfresh Gel)
triclosan/fluoride toothpaste
triclosan/fluoride/metal salt toothpaste
Overall Number of Participants Analyzed 32 33 33
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.91  (0.91) 0.84  (0.25) 1.77  (0.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Control, Positive Control, Experimental
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 Gingivitis Index
Hide Description Gingivitis score- 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 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Control Positive Control Experimental
Hide Arm/Group Description:
fluoride toothpaste
triclosan/fluoride toothpaste
triclosan/fluoride/zinc toothpaste
Overall Number of Participants Analyzed 32 33 33
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.63  (0.15) 0.51  (0.17) 0.98  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Control, Positive Control, Experimental
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 7 weeks (1 week washout and 6 week study test period)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Control Positive Control Experimental
Hide Arm/Group Description fluoride toothpaste (Winterfresh Gel) triclosan/fluoride toothpaste triclosan/fluoride/metal salt toothpaste
All-Cause Mortality
Placebo Control Positive Control Experimental
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Control Positive Control Experimental
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/34 (0.00%)   0/34 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Control Positive Control Experimental
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/34 (0.00%)   0/34 (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
Phone: 732-878-7901
EMail: william_devizio@colpal.com
Layout table for additonal information
Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00926029     History of Changes
Other Study ID Numbers: CRO-2007-GIN-06-RR
First Submitted: September 26, 2008
First Posted: June 23, 2009
Results First Submitted: September 26, 2008
Results First Posted: June 23, 2009
Last Update Posted: February 17, 2012