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Investigation of Dental Plaque and Gingival Index

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ClinicalTrials.gov Identifier: NCT00759031
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : November 25, 2008
Last Update Posted : April 13, 2012
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Dental Plaque
Interventions Drug: Sodium Monofluorophosphate
Drug: Triclosan/Fluoride/Copolymer
Enrollment 19
Recruitment Details At clinical site
Pre-assignment Details  
Arm/Group Title Fluoride 1st, Triclosan +Fluoride 2nd Triclosan + Fluoride 1st, Fluoride 2nd
Hide Arm/Group Description Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment. Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
Period Title: First Intervention (1 Day)
Started 10 9
Completed 8 8
Not Completed 2 1
Reason Not Completed
Physician Decision             1             0
Withdrawal by Subject             0             1
Screening failure             1             0
Period Title: Washout After 1st Intervention (1 Week)
Started 8 8
Completed 8 8
Not Completed 0 0
Period Title: Second Intervention (1 Day)
Started 8 8
Completed 8 8
Not Completed 0 0
Arm/Group Title Fluoride 1st, Then Triclosan +Fluoride 2nd Triclosan + Fluoride 1st, Then Fluoride 2nd Total
Hide Arm/Group Description Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment. Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment. Total of all reporting groups
Overall Number of Baseline Participants 10 9 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
9
 100.0%
19
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 9 participants 19 participants
32.1  (11.14) 33  (8.7) 32.53  (9.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
Female
8
  80.0%
8
  88.9%
16
  84.2%
Male
2
  20.0%
1
  11.1%
3
  15.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 9 participants 19 participants
10 9 19
1.Primary Outcome
Title Gingival Margin Plaque Index
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). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoride Triclosan + Fluoride
Hide Arm/Group Description:
Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours.
Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: Units on a scale
15.4  (14.74) 12.81  (14.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoride, Triclosan + Fluoride
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 3 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluoride Triclosan + Fluoride
Hide Arm/Group Description Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours.
All-Cause Mortality
Fluoride Triclosan + Fluoride
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fluoride Triclosan + Fluoride
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluoride Triclosan + Fluoride
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/17 (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: NCT00759031     History of Changes
Other Study ID Numbers: CRO-2007-PLA-23-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: April 13, 2012