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Clinical Study to Compare Dental Plaque Control

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ClinicalTrials.gov Identifier: NCT00758394
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : November 19, 2008
Last Update Posted : August 15, 2013
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 29
Recruitment Details At clinical site
Pre-assignment Details  
Arm/Group Title Fluoride First Triclosan/Fluoride First Triclosan/Fluoride/Arginine First Triclosan/Fluoride/Cavistat First
Hide Arm/Group Description Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last
Period Title: 1st Intervention
Started 8 7 6 8
Completed 8 7 6 8
Not Completed 0 0 0 0
Period Title: Washout After 1st Intervention
Started 8 7 6 8
Completed 8 7 6 8
Not Completed 0 0 0 0
Period Title: 2nd Intervention Order
Started 8 7 6 8
Completed 8 6 6 8
Not Completed 0 1 0 0
Reason Not Completed
Lost to Follow-up             0             1             0             0
Period Title: Washout After 2nd Intervention
Started 8 6 6 8
Completed 8 6 6 8
Not Completed 0 0 0 0
Period Title: 3rd Intervention
Started 8 6 6 8
Completed 7 6 6 7
Not Completed 1 0 0 1
Reason Not Completed
Lost to Follow-up             1             0             0             1
Period Title: Washout After 3rd Intervention
Started 7 6 6 7
Completed 7 6 6 7
Not Completed 0 0 0 0
Period Title: 4th Intervention
Started 7 6 6 7
Completed 7 6 6 7
Not Completed 0 0 0 0
Arm/Group Title Fluoride - A Fluoride/Triclosan - B Triclosan/Fluoride/Arginine Triclosan/Fluoride/Cavistat Total
Hide Arm/Group Description Negative control Positive control comparator toothpaste containing amino acid toothpaste containing bicarbonate Total of all reporting groups
Overall Number of Baseline Participants 8 7 6 8 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 6 participants 8 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
7
 100.0%
6
 100.0%
8
 100.0%
29
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 7 participants 6 participants 8 participants 29 participants
30.5  (10.8) 29.7  (8.7) 36.4  (11.6) 37.8  (5.0) 33.6  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 6 participants 8 participants 29 participants
Female
6
  75.0%
7
 100.0%
6
 100.0%
4
  50.0%
23
  79.3%
Male
2
  25.0%
0
   0.0%
0
   0.0%
4
  50.0%
6
  20.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 7 participants 6 participants 8 participants 29 participants
8 7 6 8 29
1.Primary Outcome
Title Dental Plaque Index
Hide Description plaque units measured on a scale between 0 to 5. 0 = No plaque; 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 - A Fluoride/Triclosan - B Triclosan/Fluoride/Arginine Triclosan/Fluoride/Cavistat
Hide Arm/Group Description:
Negative control
Positive control comparator
toothpaste containing amino acid
toothpaste containing bicarbonate
Overall Number of Participants Analyzed 7 6 6 7
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.12  (0.38) 2.90  (0.36) 2.92  (0.42) 2.94  (0.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoride - A, Fluoride/Triclosan - B, Triclosan/Fluoride/Arginine, Triclosan/Fluoride/Cavistat
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 Two way Anova general linear model (subject and treatment as factors). Multiple comparison completed to determine differences between groups.
Method ANOVA
Comments [Not Specified]
Time Frame 8 weeks (including all washout periods and four (4) study intervention periods of 4 days each).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluoride First Triclosan/Fluoride First Triclosan/Fluoride/Arginine First Triclosan/Fluoride/Cavistat First
Hide Arm/Group Description Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last
All-Cause Mortality
Fluoride First Triclosan/Fluoride First Triclosan/Fluoride/Arginine First Triclosan/Fluoride/Cavistat First
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fluoride First Triclosan/Fluoride First Triclosan/Fluoride/Arginine First Triclosan/Fluoride/Cavistat First
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/29 (0.00%)   0/29 (0.00%)   0/29 (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 First Triclosan/Fluoride First Triclosan/Fluoride/Arginine First Triclosan/Fluoride/Cavistat First
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/29 (0.00%)   0/29 (0.00%)   0/29 (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: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00758394     History of Changes
Other Study ID Numbers: CRO-0907-PLA-14-RR
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: October 16, 2008
Results First Posted: November 19, 2008
Last Update Posted: August 15, 2013