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Trial record 3 of 43 for:    FLUORIDE ION AND TRICLOSAN

Clinical Study Comparing Dental Plaque and Gingivitis Reduction After Using One of Three Oral Hygiene Multi-component Regimens (Using of a Manual Toothbrush, a Toothpaste and a Mouthwash)

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ClinicalTrials.gov Identifier: NCT02366689
Recruitment Status : Completed
First Posted : February 19, 2015
Results First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Dental Plaque
Gingivitis
Interventions Drug: Triclosan/fluoride toothpaste
Drug: stannous fluoride toothpaste
Drug: fluoride only toothpaste
Drug: Cetylpyridinium chloride mouthwash
Drug: Fluoride only mouthwash
Enrollment 179
Recruitment Details recruitment of subjects is done locally by the clinical site
Pre-assignment Details No washout or pre-assignment phase
Arm/Group Title Toothpaste Toothpaste + Mouthwash Fluoride Only Toothpaste + Mouthwash
Hide Arm/Group Description

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).

Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.

Fluoride only toothpaste + Fluoride only Mouthwash

fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.

Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.

Period Title: Overall Study
Started 60 58 61
Completed 56 55 59
Not Completed 4 3 2
Reason Not Completed
Withdrawal by Subject             1             0             1
Lost to Follow-up             3             2             0
Pregnancy             0             1             1
Arm/Group Title Toothpaste Toothpaste + Mouthwash Fluoride Only Toothpaste + Mouthwash Total
Hide Arm/Group Description

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).

Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.

Fluoride only toothpaste + Fluoride only Mouthwash

fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.

Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.

Total of all reporting groups
Overall Number of Baseline Participants 60 58 61 179
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 58 participants 61 participants 179 participants
50.09  (11.72) 48.65  (12.84) 48.51  (12.90) 49.08  (12.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 58 participants 61 participants 179 participants
Female
47
  78.3%
52
  89.7%
47
  77.0%
146
  81.6%
Male
13
  21.7%
6
  10.3%
14
  23.0%
33
  18.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 58 participants 61 participants 179 participants
60 58 61 179
1.Primary Outcome
Title Dental Plaque Scores
Hide Description Dental Plaque (Quigley-Hein, Turesky Modification Index) 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 Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Toothpaste Toothpaste + Mouthwash Fluoride Only Toothpaste + Mouthwash
Hide Arm/Group Description:

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).

Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.

Fluoride only toothpaste + Fluoride only Mouthwash

fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.

Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.

Overall Number of Participants Analyzed 60 58 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.33  (0.28) 3.22  (0.27) 3.34  (0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Toothpaste, Toothpaste + Mouthwash, Fluoride Only Toothpaste + Mouthwash
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 0.04
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Dental Plaque Scores
Hide Description Dental Plaque (Quigley-Hein, Turesky Modification Index) 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 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Toothpaste Toothpaste + Mouthwash Fluoride Only Toothpaste + Mouthwash
Hide Arm/Group Description:

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).

Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.

Fluoride only toothpaste + Fluoride only Mouthwash

fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.

Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.

Overall Number of Participants Analyzed 56 57 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.26  (0.23) 2.42  (0.22) 2.66  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Toothpaste, Toothpaste + Mouthwash, Fluoride Only Toothpaste + Mouthwash
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 < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Dental Plaque Scores
Hide Description Dental Plaque (Quigley-Hein, Turesky Modification Index) 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
[Not Specified]
Arm/Group Title Toothpaste Toothpaste + Mouthwash Fluoride Only Toothpaste + Mouthwash
Hide Arm/Group Description:

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).

Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.

Fluoride only toothpaste + Fluoride only Mouthwash

fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.

Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.

Overall Number of Participants Analyzed 56 55 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.84  (0.25) 1.86  (0.29) 2.37  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Toothpaste, Toothpaste + Mouthwash, Fluoride Only Toothpaste + Mouthwash
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 <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Primary Outcome
Title Gingivitis Scores
Hide Description Gingivitis scale (Loe & Silness Gingival Index) 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 Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Toothpaste Toothpaste + Mouthwash Fluoride Only Toothpaste + Mouthwash
Hide Arm/Group Description:

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).

Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.

Fluoride only toothpaste + Fluoride only Mouthwash

fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.

Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.

Overall Number of Participants Analyzed 60 58 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.18  (0.16) 2.17  (0.22) 2.22  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Toothpaste, Toothpaste + Mouthwash, Fluoride Only Toothpaste + Mouthwash
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 0.432
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Primary Outcome
Title Gingivitis Scores
Hide Description Gingivitis scale (Loe & Silness Gingival Index) 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 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Toothpaste Toothpaste + Mouthwash Fluoride Only Toothpaste + Mouthwash
Hide Arm/Group Description:

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).

Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.

Fluoride only toothpaste + Fluoride only Mouthwash

fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.

Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.

Overall Number of Participants Analyzed 56 56 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.48  (0.15) 1.65  (0.16) 1.89  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Toothpaste, Toothpaste + Mouthwash, Fluoride Only Toothpaste + Mouthwash
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 <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Primary Outcome
Title Gingivitis Scores
Hide Description Gingivitis scale (Loe & Silness Gingival Index) 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 Toothpaste Toothpaste + Mouthwash Fluoride Only Toothpaste + Mouthwash
Hide Arm/Group Description:

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).

Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.

Fluoride only toothpaste + Fluoride only Mouthwash

fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.

Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.

Overall Number of Participants Analyzed 56 55 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.17  (0.14) 1.18  (0.12) 1.85  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Toothpaste, Toothpaste + Mouthwash, Fluoride Only Toothpaste + Mouthwash
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 <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Baseline, 3 months and 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Toothpaste Toothpaste + Mouthwash Fluoride Only Toothpaste + Mouthwash
Hide Arm/Group Description

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).

Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.

Fluoride only toothpaste + Fluoride only Mouthwash

fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.

Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.

All-Cause Mortality
Toothpaste Toothpaste + Mouthwash Fluoride Only Toothpaste + Mouthwash
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Toothpaste Toothpaste + Mouthwash Fluoride Only Toothpaste + Mouthwash
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/58 (0.00%)   0/61 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Toothpaste Toothpaste + Mouthwash Fluoride Only Toothpaste + Mouthwash
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/58 (0.00%)   0/61 (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: Dr. Farid Ayad
Organization: Farid Ayad
Phone: 416-473-1189
EMail: ayad.farid@gmail.com
Layout table for additonal information
Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT02366689     History of Changes
Other Study ID Numbers: CRO-2014-05-PG-6MCTCPG-ED
First Submitted: February 6, 2015
First Posted: February 19, 2015
Results First Submitted: January 28, 2016
Results First Posted: March 30, 2016
Last Update Posted: March 30, 2016