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Clinical Study to Evaluate Dental Plaque

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ClinicalTrials.gov Identifier: NCT00758290
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : November 25, 2008
Last Update Posted : November 25, 2008
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 Gingival Diseases
Interventions Drug: Triclosan/Fluoride
Drug: Fluoride/triclosan
Enrollment 23
Recruitment Details At clinical site
Pre-assignment Details  
Arm/Group Title Fluoride/Triclosan Triclosan/Fluoride
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 11 12
Completed 11 12
Not Completed 0 0
Arm/Group Title Fluoride/Triclosan Triclosan/Fluoride Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 11 12 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
12
 100.0%
23
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Twenty four panelists were enrolled, but 1 was discontinued due to non-compliance with study visits. Twenty three panelists comleted study.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 12 participants 23 participants
32.5  (11.7) 30.3  (7.1) 31.4  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
Female
11
 100.0%
8
  66.7%
19
  82.6%
Male
0
   0.0%
4
  33.3%
4
  17.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 12 participants 23 participants
11 12 23
1.Primary Outcome
Title Dental Plaque Index
Hide Description Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque
Time Frame 4 Day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoride/Triclosan Triclosan/Fluoride
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.48  (0.34) 2.42  (0.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoride/Triclosan, Triclosan/Fluoride
Comments [Not Specified]
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]
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- Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00758290     History of Changes
Other Study ID Numbers: CRO-2008-PLA-13-RR
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: October 16, 2008
Results First Posted: November 25, 2008
Last Update Posted: November 25, 2008