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Trial record 16 of 43 for:    FLUORIDE ION AND TRICLOSAN

Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

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ClinicalTrials.gov Identifier: NCT00926328
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : June 23, 2009
Last Update Posted : August 15, 2013
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Gingivitis
Interventions Drug: Triclosan, fluoride
Drug: Fluoride
Enrollment 120
Recruitment Details Performed by the Research Department School of Dentistry UPR
Pre-assignment Details  
Arm/Group Title Experimental Treatment Placebo Control
Hide Arm/Group Description triclosan/copolymer/fluoride toothpaste sodium fluoride toothpaste
Period Title: Overall Study
Started 60 60
Completed 48 46
Not Completed 12 14
Reason Not Completed
Lost to Follow-up             12             14
Arm/Group Title Experimental Treatment Placebo Control Total
Hide Arm/Group Description triclosan/copolymer/fluoride toothpaste sodium fluoride toothpaste Total of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
58
  96.7%
58
  96.7%
116
  96.7%
>=65 years
2
   3.3%
2
   3.3%
4
   3.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
34.72  (8.51) 35.95  (10.24) 35.33  (9.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
45
  75.0%
43
  71.7%
88
  73.3%
Male
15
  25.0%
17
  28.3%
32
  26.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 60 participants 60 participants 120 participants
60 60 120
1.Primary Outcome
Title Gingivitis Index
Hide Description

Units on a scale 0 to 3 (0 = no inflammation ,

1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing.

3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental Treatment Placebo Control
Hide Arm/Group Description:
triclosan/copolymer/fluoride toothpaste
sodium fluoride toothpaste
Overall Number of Participants Analyzed 48 46
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.00  (0.17) 1.27  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Treatment, Placebo Control
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 ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Plaque Index
Hide Description 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 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Experimental Treatment Placebo Control
Hide Arm/Group Description:
triclosan/copolymer/fluoride toothpaste
sodium fluoride toothpaste
Overall Number of Participants Analyzed 48 46
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.22  (0.49) 2.88  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Treatment, Placebo Control
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 ANCOVA
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Treatment Placebo Control
Hide Arm/Group Description triclosan/copolymer/fluoride toothpaste sodium fluoride toothpaste
All-Cause Mortality
Experimental Treatment Placebo Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Treatment Placebo Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental Treatment Placebo Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (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 De Vizio, 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: NCT00926328     History of Changes
Other Study ID Numbers: CRO-0507-PL-SP-CT-BS
First Submitted: September 26, 2008
First Posted: June 23, 2009
Results First Submitted: September 26, 2008
Results First Posted: June 23, 2009
Last Update Posted: August 15, 2013