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Trial record 22 of 43 for:    FLUORIDE ION AND TRICLOSAN

Evaluating Commercial Anti-Plaque Products and Oral Rinse

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ClinicalTrials.gov Identifier: NCT01014143
Recruitment Status : Completed
First Posted : November 16, 2009
Results First Posted : November 16, 2009
Last Update Posted : June 14, 2011
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: Chlorhexidine digluconate
Drug: Fluoride, triclosan
Enrollment 26
Recruitment Details Recruitment was performed by the clinical site
Pre-assignment Details  
Arm/Group Title Fluoride Toothpaste First Total Toothpaste First Chlorhexidine Oral Rinse First
Hide Arm/Group Description Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
Period Title: First Intervention
Started 10 9 9
Completed 10 9 9
Not Completed 0 0 0
Period Title: Washout Period After 1st Intervention
Started 10 9 9
Completed 10 9 9
Not Completed 0 0 0
Period Title: Second Intervention
Started 10 9 9
Completed 8 9 9
Not Completed 2 0 0
Reason Not Completed
Lost to Follow-up             2             0             0
Period Title: Washout After 2nd Intervention
Started 8 9 9
Completed 8 9 9
Not Completed 0 0 0
Period Title: Third Intervention
Started 8 9 9
Completed 8 9 9
Not Completed 0 0 0
Arm/Group Title Fluoride Toothpaste Total Toothpaste Chlorhexidine Oral Rinse Total
Hide Arm/Group Description negative control triclosan/fluoride toothpaste (positive control toothpaste) chlorhexidine mouthrinse (positive control rinse) Total of all reporting groups
Overall Number of Baseline Participants 10 9 9 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 9 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
9
 100.0%
9
 100.0%
28
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 9 participants 9 participants 28 participants
47.6  (15.1) 39  (9.2) 47.2  (9.6) 44.5  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 9 participants 28 participants
Female
7
  70.0%
6
  66.7%
9
 100.0%
22
  78.6%
Male
3
  30.0%
3
  33.3%
0
   0.0%
6
  21.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 9 participants 9 participants 28 participants
10 9 9 28
1.Primary Outcome
Title Plaque Index
Hide Description Plaque 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 Four days
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol. 2 subjects missed appointments and did not complete two of the study treatment periods.
Arm/Group Title Fluoride Toothpaste Total Toothpaste Chlorhexidine Oral Rinse
Hide Arm/Group Description:
negative control
triclosan/fluoride toothpaste (positive control toothpaste)
chlorhexidine mouthrinse (positive control rinse)
Overall Number of Participants Analyzed 28 26 26
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.63  (0.61) 2.65  (0.56) 1.23  (0.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoride Toothpaste, Total Toothpaste, Chlorhexidine Oral Rinse
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 6 weeks
Adverse Event Reporting Description subjects were examined at each clinic visit for any signs of side effects while using the study products. If any subject developed any potential side effect while using the study products, they called 24 hour contact number to report it and made an appointment with the clinician to have the side effect evaluated.
 
Arm/Group Title Fluoride Toothpaste First Total Toothpaste First Chlorhexidine Oral Rinse First
Hide Arm/Group Description Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
All-Cause Mortality
Fluoride Toothpaste First Total Toothpaste First Chlorhexidine Oral Rinse First
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluoride Toothpaste First Total Toothpaste First Chlorhexidine Oral Rinse First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/28 (0.00%)      0/28 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fluoride Toothpaste First Total Toothpaste First Chlorhexidine Oral Rinse First
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/28 (3.57%)      1/28 (3.57%)      1/28 (3.57%)    
Social circumstances       
Upset stomach - non related to product use * [1]  1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0
Sinus headache - non related to product use * [1]  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0
Menstrual cramps * [1]  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1
*
Indicates events were collected by non-systematic assessment
[1]
All events resolved in the same day to 3 days after reporting. Adverse events reported in this study were determined not to be related to study product use.
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: NCT01014143     History of Changes
Other Study ID Numbers: CRO-2007-PLA-15-RR
First Submitted: September 26, 2008
First Posted: November 16, 2009
Results First Submitted: September 26, 2008
Results First Posted: November 16, 2009
Last Update Posted: June 14, 2011