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The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US

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ClinicalTrials.gov Identifier: NCT02360995
Recruitment Status : Completed
First Posted : February 11, 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 toothpaste
Drug: Fluoride Mouthwash
Drug: cetylpyridinium chloride Mouthwash
Enrollment 129

Recruitment Details Subject recruitment is completed locally by the clinical site
Pre-assignment Details There is no wash out or pre-assignment of any study product.
Arm/Group Title Total Toothpaste Toothpaste + Mouthwash Control Group
Hide Arm/Group Description

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).

Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.

fluoride toothpaste +fluoride mouthwash

fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.

Period Title: Overall Study
Started 43 43 43
Completed 41 42 41
Not Completed 2 1 2
Reason Not Completed
Lost to Follow-up             2             0             2
Withdrawal by Subject             0             1             0
Arm/Group Title Total Toothpaste Toothpaste + Mouthwash Control Group Total
Hide Arm/Group Description

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).

Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.

fluoride toothpaste +fluoride mouthwash

fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.

Total of all reporting groups
Overall Number of Baseline Participants 43 43 43 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 43 participants 43 participants 129 participants
44.68  (16.85) 44.90  (15.51) 44.39  (13.68) 44.47  (15.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 43 participants 43 participants 129 participants
Female
23
  53.5%
25
  58.1%
24
  55.8%
72
  55.8%
Male
20
  46.5%
18
  41.9%
19
  44.2%
57
  44.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants 43 participants 43 participants 129 participants
43 43 43 129
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Toothpaste + Mouthwash Control Group
Hide Arm/Group Description:

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).

Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.

fluoride toothpaste +fluoride mouthwash

fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.

Overall Number of Participants Analyzed 43 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.91  (0.31) 3.86  (0.45) 3.84  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Toothpaste + Mouthwash, Control Group
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 0.652
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 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Toothpaste + Mouthwash Control Group
Hide Arm/Group Description:

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).

Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.

fluoride toothpaste +fluoride mouthwash

fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.

Overall Number of Participants Analyzed 41 42 41
Mean (Standard Error)
Unit of Measure: units on a scale
3.42  (0.06) 3.69  (0.06) 3.73  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Toothpaste + Mouthwash, Control Group
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 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Toothpaste + Mouthwash Control Group
Hide Arm/Group Description:

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).

Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.

fluoride toothpaste +fluoride mouthwash

fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.

Overall Number of Participants Analyzed 41 42 41
Mean (Standard Error)
Unit of Measure: units on a scale
1.05  (0.04) 1.15  (0.04) 1.24  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Toothpaste + Mouthwash, Control Group
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Toothpaste + Mouthwash Control Group
Hide Arm/Group Description:

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).

Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.

fluoride toothpaste +fluoride mouthwash

fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.

Overall Number of Participants Analyzed 43 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.38  (0.22) 1.35  (0.24) 1.41  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Toothpaste + Mouthwash, Control Group
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 0.533
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 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Toothpaste + Mouthwash Control Group
Hide Arm/Group Description:

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).

Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.

fluoride toothpaste +fluoride mouthwash

fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.

Overall Number of Participants Analyzed 41 42 41
Mean (Standard Error)
Unit of Measure: units on a scale
1.15  (0.04) 1.20  (0.04) 1.30  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Toothpaste + Mouthwash, Control Group
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 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Toothpaste + Mouthwash Control Group
Hide Arm/Group Description:

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).

Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.

fluoride toothpaste +fluoride mouthwash

fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.

Overall Number of Participants Analyzed 41 42 41
Mean (Standard Error)
Unit of Measure: units on a scale
1.05  (0.04) 1.15  (0.04) 1.24  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Control Group
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, 4 and 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Total Toothpaste Toothpaste + Mouthwash Control Group
Hide Arm/Group Description

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).

Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.

fluoride toothpaste +fluoride mouthwash

fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.

All-Cause Mortality
Total Toothpaste Toothpaste + Mouthwash Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Total Toothpaste Toothpaste + Mouthwash Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/43 (0.00%)   0/43 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Total Toothpaste Toothpaste + Mouthwash Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/43 (0.00%)   0/43 (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
Name/Title: Yiming Li, DDS
Organization: Loma Linda University School of Dentistry
Phone: 909-558-8069
EMail: yli@llu.edu
Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT02360995     History of Changes
Other Study ID Numbers: CRO-2014-06-PLAGIN-CT-YPZ
First Submitted: February 6, 2015
First Posted: February 11, 2015
Results First Submitted: February 1, 2016
Results First Posted: March 30, 2016
Last Update Posted: March 30, 2016