Trial Outcomes & Findings for 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) (NCT NCT02366689)
NCT ID: NCT02366689
Last Updated: 2016-03-30
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
179 participants
Primary outcome timeframe
Baseline
Results posted on
2016-03-30
Participant Flow
recruitment of subjects is done locally by the clinical site
No washout or pre-assignment phase
Participant milestones
| Measure |
Toothpaste
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).
|
Toothpaste + Mouthwash
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 + Mouthwash
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 Study
STARTED
|
60
|
58
|
61
|
|
Overall Study
COMPLETED
|
56
|
55
|
59
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
2
|
Reasons for withdrawal
| Measure |
Toothpaste
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).
|
Toothpaste + Mouthwash
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 + Mouthwash
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 Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
1
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Toothpaste
n=60 Participants
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).
|
Toothpaste + Mouthwash
n=58 Participants
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 + Mouthwash
n=61 Participants
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
n=179 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.09 years
STANDARD_DEVIATION 11.72 • n=5 Participants
|
48.65 years
STANDARD_DEVIATION 12.84 • n=7 Participants
|
48.51 years
STANDARD_DEVIATION 12.90 • n=5 Participants
|
49.08 years
STANDARD_DEVIATION 12.49 • n=4 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
58 participants
n=7 Participants
|
61 participants
n=5 Participants
|
179 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: BaselineDental 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)
Outcome measures
| Measure |
Toothpaste
n=60 Participants
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).
|
Toothpaste + Mouthwash
n=58 Participants
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 + Mouthwash
n=61 Participants
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.
|
|---|---|---|---|
|
Dental Plaque Scores
|
3.33 units on a scale
Standard Deviation 0.28
|
3.22 units on a scale
Standard Deviation 0.27
|
3.34 units on a scale
Standard Deviation 0.26
|
PRIMARY outcome
Timeframe: 3 monthsDental 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)
Outcome measures
| Measure |
Toothpaste
n=56 Participants
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).
|
Toothpaste + Mouthwash
n=57 Participants
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 + Mouthwash
n=59 Participants
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.
|
|---|---|---|---|
|
Dental Plaque Scores
|
2.26 units on a scale
Standard Deviation 0.23
|
2.42 units on a scale
Standard Deviation 0.22
|
2.66 units on a scale
Standard Deviation 0.23
|
PRIMARY outcome
Timeframe: 6 monthsDental 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)
Outcome measures
| Measure |
Toothpaste
n=56 Participants
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).
|
Toothpaste + Mouthwash
n=55 Participants
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 + Mouthwash
n=59 Participants
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.
|
|---|---|---|---|
|
Dental Plaque Scores
|
1.84 units on a scale
Standard Deviation 0.25
|
1.86 units on a scale
Standard Deviation 0.29
|
2.37 units on a scale
Standard Deviation 0.32
|
PRIMARY outcome
Timeframe: BaselineGingivitis 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)
Outcome measures
| Measure |
Toothpaste
n=60 Participants
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).
|
Toothpaste + Mouthwash
n=58 Participants
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 + Mouthwash
n=61 Participants
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.
|
|---|---|---|---|
|
Gingivitis Scores
|
2.18 units on a scale
Standard Deviation 0.16
|
2.17 units on a scale
Standard Deviation 0.22
|
2.22 units on a scale
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: 3 monthsGingivitis 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)
Outcome measures
| Measure |
Toothpaste
n=56 Participants
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).
|
Toothpaste + Mouthwash
n=56 Participants
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 + Mouthwash
n=59 Participants
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.
|
|---|---|---|---|
|
Gingivitis Scores
|
1.48 units on a scale
Standard Deviation 0.15
|
1.65 units on a scale
Standard Deviation 0.16
|
1.89 units on a scale
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: 6 monthsGingivitis 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)
Outcome measures
| Measure |
Toothpaste
n=56 Participants
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).
|
Toothpaste + Mouthwash
n=55 Participants
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 + Mouthwash
n=59 Participants
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.
|
|---|---|---|---|
|
Gingivitis Scores
|
1.17 units on a scale
Standard Deviation 0.14
|
1.18 units on a scale
Standard Deviation 0.12
|
1.85 units on a scale
Standard Deviation 0.13
|
Adverse Events
Toothpaste
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Toothpaste + Mouthwash
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fluoride Only Toothpaste + Mouthwash
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60