Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluate Clinical Research From Commerical Oral Care Products

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: NCT00759187
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : November 18, 2008
Last Update Posted : March 4, 2010
Sponsor:
Information provided by:
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Gingival Diseases
Interventions Drug: Fluoride
Drug: Triclosan/Fluoride
Drug: Chlorhexidine Gluconate
Enrollment 25
Recruitment Details At clinical site
Pre-assignment Details  
Arm/Group Title Fluoride Fluoride/Triclosan Chlorhexidine Gluconate
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 8 8 9
Completed 8 8 9
Not Completed 0 0 0
Arm/Group Title Fluoride Fluoride/Triclosan Chlorhexidine Gluconate Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 8 8 9 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 9 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
8
 100.0%
9
 100.0%
25
 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 8 participants 8 participants 9 participants 25 participants
29.4  (6.9) 32.6  (8.8) 33.1  (9.0) 31.8  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 9 participants 25 participants
Female
8
 100.0%
7
  87.5%
8
  88.9%
23
  92.0%
Male
0
   0.0%
1
  12.5%
1
  11.1%
2
   8.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 9 participants 25 participants
8 8 9 25
1.Primary Outcome
Title Dental Plaque Index
Hide Description Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)
Time Frame 4-Day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoride Fluoride/Triclosan Chlorhexidine Gluconate
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 9 8 8
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.79  (0.37) 2.82  (0.39) 1.99  (0.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoride, Fluoride/Triclosan, Chlorhexidine Gluconate
Comments [Not Specified]
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)
Method ANOVA
Comments [Not Specified]
Time Frame 4 day treatment period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluoride Fluoride/Triclosan Chlorhexidine Gluconate
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Fluoride Fluoride/Triclosan Chlorhexidine Gluconate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluoride Fluoride/Triclosan Chlorhexidine Gluconate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/8 (0.00%)      0/8 (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 Fluoride/Triclosan Chlorhexidine Gluconate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/9 (66.67%)      1/8 (12.50%)      0/8 (0.00%)    
General disorders       
Canker sore * [1]  1/9 (11.11%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Cold symptoms * [2]  4/9 (44.44%)  4 0/8 (0.00%)  0 0/8 (0.00%)  0
Conjunctivitis * [3]  1/9 (11.11%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Heavy menstrual bleeding * [4]  0/9 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Aphtous lesion (canker sore) reported by patient. Patient history determined that canker sores occur after eating spicy food. Sore abated without treatment. Relationship to study product use doubtful.
[2]
patient reported feeling cold symptoms. Events noted before treatment period started. Patients were on washout toothpaste (fluoride toothpaste). Relationship to study product use doubtful.
[3]
Patient reported conjuctivitis and was treated with antibiotics. Event occurred during the washout period (fluoride toothpaste) and abated after antibiotic use. Relationship to product use doubtful.
[4]
Patient reported heavy menstrual bleeding and took OTC medication and vitamins on her own. Symptoms abated after 2 days. Relationship to product use doubtful.
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: NCT00759187     History of Changes
Other Study ID Numbers: CRO-0607-PLA-11-RR
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: October 16, 2008
Results First Posted: November 18, 2008
Last Update Posted: March 4, 2010