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Train New Examiners Via Modified Gingival Margin Plaque

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ClinicalTrials.gov Identifier: NCT00758563
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : November 20, 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 Dental Plaque
Interventions Drug: Fluoride
Drug: Triclosan/Fluoride
Enrollment 15
Recruitment Details At clinical site
Pre-assignment Details  
Arm/Group Title Fluoride Triclosan
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 7 8
Completed 7 8
Not Completed 0 0
Arm/Group Title Fluoride Triclosan Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 7 8 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 8 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
8
 100.0%
15
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 8 participants 15 participants
34.3  (17.4) 32.1  (11.5) 33.1  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 8 participants 15 participants
Female
6
  85.7%
7
  87.5%
13
  86.7%
Male
1
  14.3%
1
  12.5%
2
  13.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 8 participants 15 participants
7 8 15
1.Primary Outcome
Title Mean Gingival Plaque Units
Hide Description Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque).
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoride Triclosan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 7 8
Mean (Standard Deviation)
Unit of Measure: Units on a scale
13.38  (13.65) 14.29  (12.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoride, Triclosan
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: NCT00758563     History of Changes
Other Study ID Numbers: CRO-0907-PLA-18-RR
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: October 16, 2008
Results First Posted: November 20, 2008
Last Update Posted: November 25, 2008