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Trial record 20 of 43 for:    FLUORIDE ION AND TRICLOSAN

Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.

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: NCT00966953
Recruitment Status : Completed
First Posted : August 27, 2009
Results First Posted : August 27, 2009
Last Update Posted : September 22, 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 Gingival Diseases
Interventions Drug: Fluoride
Drug: Triclosan/Fluoride toothpaste
Other: antibacterial plant extract
Enrollment 25
Recruitment Details The dental clinic staff recruited for this study.
Pre-assignment Details  
Arm/Group Title Fluoride Control, Magnolol,Total/Whitening,Honokiol Total/Whitening, Honokiol, Fluoride Control, Magnolol Honokiol, Fluoride Control, Magnolol, Total/Whitening Magnolol, Total/Whitening, Honokiol, Fluoride Control
Hide Arm/Group Description 1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol 1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol 1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control 1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control
Period Title: 1st Intervention
Started 6 6 6 7
Completed 6 6 6 7
Not Completed 0 0 0 0
Period Title: 1 Week Washout After 1st Intervention
Started 6 6 6 7
Completed 6 6 6 7
Not Completed 0 0 0 0
Period Title: 2nd Intervention
Started 6 6 6 7
Completed 6 6 6 7
Not Completed 0 0 0 0
Period Title: 1 Week Washout After 2nd Intervention
Started 6 6 6 7
Completed 6 6 6 7
Not Completed 0 0 0 0
Period Title: 3rd Intervention Order
Started 6 6 6 7
Completed 6 6 6 7
Not Completed 0 0 0 0
Period Title: 1 Week Washout After 3rd Intervention
Started 6 6 6 7
Completed 6 6 6 7
Not Completed 0 0 0 0
Period Title: 4th Intervention Order
Started 6 6 6 7
Completed 6 6 6 7
Not Completed 0 0 0 0
Arm/Group Title Fluoride Control, Magnolol,Total/Whitening,Honokiol Total/Whitening, Honokiol, Fluoride Control, Magnolol Honokiol, Fluoride Control, Magnolol, Total/Whitening Magnolol, Total/Whitening, Honokiol, Fluoride Control Total
Hide Arm/Group Description 1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol 1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol 1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control 1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 7 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 7 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
6
 100.0%
7
 100.0%
25
 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 6 participants 6 participants 6 participants 7 participants 25 participants
42  (11.8) 37.8  (11.6) 46.4  (10.9) 44.3  (7) 42.1  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 7 participants 25 participants
Female
2
  33.3%
3
  50.0%
3
  50.0%
7
 100.0%
15
  60.0%
Male
4
  66.7%
3
  50.0%
3
  50.0%
0
   0.0%
10
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 6 participants 7 participants 25 participants
6 6 6 7 25
1.Primary Outcome
Title Plaque Index
Hide Description Plaque score scale: 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 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoride Only Total/Whitening Herbal Extract Toothpaste Herbal Extract Toothpaste
Hide Arm/Group Description:
Control toothopaste
Control toothpaste
Fluoride/Honokiol extract toothpaste
Fluoride/Magnolol extract toothpaste
Overall Number of Participants Analyzed 25 25 25 25
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.45  (0.47) 2.22  (0.46) 2.54  (0.44) 2.56  (0.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoride Only, Total/Whitening, Herbal Extract Toothpaste, Herbal Extract Toothpaste
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]
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: NCT00966953     History of Changes
Other Study ID Numbers: ERO-0907-PLA-16-RR
First Submitted: September 26, 2008
First Posted: August 27, 2009
Results First Submitted: September 26, 2008
Results First Posted: August 27, 2009
Last Update Posted: September 22, 2009