Trial Outcomes & Findings for The Clinical Efficacy of Three Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Dental Plaque and Gingivitis (NCT NCT02193165)
NCT ID: NCT02193165
Last Updated: 2015-08-17
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
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
Baseline
Results posted on
2015-08-17
Participant Flow
recruitment at clinical site
There is no wash-out period prior to product randomization and distribution. Each subject was randomized and given a study treatment to follow after successfully completing the study screening procedures.
Participant milestones
| Measure |
Regimen 1
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.
|
Regimen 2
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.
|
Regimen 3 - Control Group
fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
|
|---|---|---|---|
|
4 Week Product Use
STARTED
|
40
|
40
|
40
|
|
4 Week Product Use
COMPLETED
|
39
|
39
|
39
|
|
4 Week Product Use
NOT COMPLETED
|
1
|
1
|
1
|
|
6 Week Product Use
STARTED
|
39
|
39
|
39
|
|
6 Week Product Use
COMPLETED
|
39
|
38
|
39
|
|
6 Week Product Use
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Regimen 1
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.
|
Regimen 2
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.
|
Regimen 3 - Control Group
fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
|
|---|---|---|---|
|
4 Week Product Use
Lost to Follow-up
|
1
|
1
|
1
|
|
6 Week Product Use
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
The Clinical Efficacy of Three Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Dental Plaque and Gingivitis
Baseline characteristics by cohort
| Measure |
Regimen 1
n=40 Participants
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.
|
Regimen 2
n=40 Participants
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.
|
Regimen 3 - Control Group
n=40 Participants
fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
40 participants
n=5 Participants
|
120 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 |
Regimen 1
n=40 Participants
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.
|
Regimen 2
n=40 Participants
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.
|
Regimen 3 - Control Group
n=40 Participants
fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
|
|---|---|---|---|
|
Dental Plaque Scores
|
3.33 units on a scale
Standard Deviation 0.52
|
3.19 units on a scale
Standard Deviation 0.53
|
3.31 units on a scale
Standard Deviation 0.48
|
PRIMARY outcome
Timeframe: 4 weeksDental 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 |
Regimen 1
n=39 Participants
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.
|
Regimen 2
n=39 Participants
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.
|
Regimen 3 - Control Group
n=39 Participants
fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
|
|---|---|---|---|
|
Dental Plaque Scores
|
2.78 units on a scale
Standard Deviation 0.56
|
2.79 units on a scale
Standard Deviation 0.52
|
3.34 units on a scale
Standard Deviation 0.48
|
PRIMARY outcome
Timeframe: 6 weeksDental 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 |
Regimen 1
n=39 Participants
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.
|
Regimen 2
n=38 Participants
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.
|
Regimen 3 - Control Group
n=39 Participants
fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
|
|---|---|---|---|
|
Dental Plaque Scores
|
2.42 units on a scale
Standard Deviation 0.62
|
2.59 units on a scale
Standard Deviation 0.58
|
3.38 units on a scale
Standard Deviation 0.49
|
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 |
Regimen 1
n=40 Participants
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.
|
Regimen 2
n=40 Participants
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.
|
Regimen 3 - Control Group
n=40 Participants
fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
|
|---|---|---|---|
|
Gingivitis Scores
|
1.40 units on a scale
Standard Deviation 0.31
|
1.40 units on a scale
Standard Deviation 0.32
|
1.44 units on a scale
Standard Deviation 0.37
|
PRIMARY outcome
Timeframe: 4 weeksGingivitis 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 |
Regimen 1
n=39 Participants
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.
|
Regimen 2
n=39 Participants
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.
|
Regimen 3 - Control Group
n=39 Participants
fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
|
|---|---|---|---|
|
Gingivitis Scores
|
1.19 units on a scale
Standard Deviation 0.23
|
1.30 units on a scale
Standard Deviation 0.27
|
1.44 units on a scale
Standard Deviation 0.37
|
PRIMARY outcome
Timeframe: 6 weeksGingivitis 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 |
Regimen 1
n=39 Participants
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.
|
Regimen 2
n=38 Participants
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.
|
Regimen 3 - Control Group
n=39 Participants
fluoride toothpaste + fluoride Mouthwash
fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
|
|---|---|---|---|
|
Gingivitis Scores
|
1.03 units on a scale
Standard Deviation 0.14
|
1.21 units on a scale
Standard Deviation 0.24
|
1.46 units on a scale
Standard Deviation 0.36
|
Adverse Events
Regimen 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Regimen 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Regimen 3 - Control Group
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