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Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse

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: NCT01024738
Recruitment Status : Completed
First Posted : December 3, 2009
Results First Posted : December 3, 2009
Last Update Posted : December 3, 2009
Sponsor:
Information provided by:
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dental Plaque
Interventions Drug: Fluoride
Drug: Triclosan, fluoride
Drug: Chlorhexidine Gluconate
Enrollment 22
Recruitment Details Performed at the clinic
Pre-assignment Details  
Arm/Group Title Fluoride Toothpaste First Triclosan/Fluoride Toothpaste First Chlorhexidine Oral Rinse
Hide Arm/Group Description Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
Period Title: First Intervention:
Started 7 7 8
Completed 7 7 8
Not Completed 0 0 0
Period Title: Washout After 1st Intervention
Started 7 7 8
Completed 7 7 8
Not Completed 0 0 0
Period Title: Second Intervention:
Started 7 7 8
Completed 7 7 8
Not Completed 0 0 0
Period Title: Washout After 2nd Intervention
Started 7 7 8
Completed 7 7 8
Not Completed 0 0 0
Period Title: Third Intervention:
Started 7 7 8
Completed 7 7 8
Not Completed 0 0 0
Arm/Group Title Fluoride Toothpaste Total Toothpaste Chlorhexidine Oral Rinse Total
Hide Arm/Group Description negative control toothpaste triclosan/fluoride toothpaste (positive control) chlorhexidine oral rinse (positive control) Total of all reporting groups
Overall Number of Baseline Participants 7 7 8 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 8 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
7
 100.0%
8
 100.0%
22
 100.0%
>=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 7 participants 7 participants 8 participants 22 participants
44.2  (10.23) 50.5  (6.5) 56.6  (5.5) 50.43  (8.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 8 participants 22 participants
Female
7
 100.0%
6
  85.7%
7
  87.5%
20
  90.9%
Male
0
   0.0%
1
  14.3%
1
  12.5%
2
   9.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 8 participants 22 participants
7 7 8 22
1.Primary Outcome
Title Plaque Index
Hide Description Plaque score is 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)
Time Frame 4 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoride Toothpaste Total Toothpaste Chlorhexidine Oral Rinse
Hide Arm/Group Description:
negative control toothpaste
triclosan/fluoride toothpaste (positive control)
chlorhexidine oral rinse (positive control)
Overall Number of Participants Analyzed 22 22 22
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.31  (0.48) 3.31  (0.38) 2.91  (0.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoride Toothpaste, Total Toothpaste, Chlorhexidine Oral Rinse
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 2 month test period
Adverse Event Reporting Description subjects used the product twice a day for 4 days with oral exams at beginning and end of treatment periods.
 
Arm/Group Title Fluoride Toothpaste First Triclosan/Fluoride Toothpaste First Chlorhexidine Oral Rinse
Hide Arm/Group Description Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
All-Cause Mortality
Fluoride Toothpaste First Triclosan/Fluoride Toothpaste First Chlorhexidine Oral Rinse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluoride Toothpaste First Triclosan/Fluoride Toothpaste First Chlorhexidine Oral Rinse
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/22 (0.00%)      0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fluoride Toothpaste First Triclosan/Fluoride Toothpaste First Chlorhexidine Oral Rinse
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/22 (0.00%)      1/22 (4.55%)    
Social circumstances       
Non related adverse event 1 [1]  0/22 (0.00%)  0 0/22 (0.00%)  0 1/22 (4.55%)  1
1
Term from vocabulary, other
[1]
subject reported a fracture in a tooth while eating white bread. Subject had the tooth repair with a composite filling. Subject continued with study without interuption. Event determined to be not related to study toothpaste or rinse use.
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: William DeVizio/VP, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT01024738     History of Changes
Other Study ID Numbers: CRO-2008-PLA-05-RR
First Submitted: September 26, 2008
First Posted: December 3, 2009
Results First Submitted: September 26, 2008
Results First Posted: December 3, 2009
Last Update Posted: December 3, 2009