Trial Outcomes & Findings for The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US (NCT NCT02360995)
NCT ID: NCT02360995
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
129 participants
Primary outcome timeframe
Baseline
Results posted on
2016-03-30
Participant Flow
Subject recruitment is completed locally by the clinical site
There is no wash out or pre-assignment of any study product.
Participant milestones
| Measure |
Total Toothpaste
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).
|
Toothpaste + Mouthwash
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.
|
Control Group
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 Study
STARTED
|
43
|
43
|
43
|
|
Overall Study
COMPLETED
|
41
|
42
|
41
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
Total Toothpaste
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).
|
Toothpaste + Mouthwash
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.
|
Control Group
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 Study
Lost to Follow-up
|
2
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US
Baseline characteristics by cohort
| Measure |
Total Toothpaste
n=43 Participants
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).
|
Toothpaste + Mouthwash
n=43 Participants
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.
|
Control Group
n=43 Participants
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
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.68 years
STANDARD_DEVIATION 16.85 • n=5 Participants
|
44.90 years
STANDARD_DEVIATION 15.51 • n=7 Participants
|
44.39 years
STANDARD_DEVIATION 13.68 • n=5 Participants
|
44.47 years
STANDARD_DEVIATION 15.26 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
43 participants
n=7 Participants
|
43 participants
n=5 Participants
|
129 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 |
Total Toothpaste
n=43 Participants
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).
|
Toothpaste + Mouthwash
n=43 Participants
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.
|
Control Group
n=43 Participants
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.
|
|---|---|---|---|
|
Dental Plaque Scores
|
3.91 units on a scale
Standard Deviation 0.31
|
3.86 units on a scale
Standard Deviation 0.45
|
3.84 units on a scale
Standard Deviation 0.23
|
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 |
Total Toothpaste
n=41 Participants
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).
|
Toothpaste + Mouthwash
n=42 Participants
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.
|
Control Group
n=41 Participants
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.
|
|---|---|---|---|
|
Dental Plaque Scores
|
3.42 units on a scale
Standard Error 0.06
|
3.69 units on a scale
Standard Error 0.06
|
3.73 units on a scale
Standard Error 0.06
|
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 |
Total Toothpaste
n=41 Participants
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).
|
Toothpaste + Mouthwash
n=42 Participants
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.
|
Control Group
n=41 Participants
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.
|
|---|---|---|---|
|
Dental Plaque Scores
|
1.05 units on a scale
Standard Error 0.04
|
1.15 units on a scale
Standard Error 0.04
|
1.24 units on a scale
Standard Error 0.04
|
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 |
Total Toothpaste
n=43 Participants
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).
|
Toothpaste + Mouthwash
n=43 Participants
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.
|
Control Group
n=43 Participants
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.
|
|---|---|---|---|
|
Gingivitis Scores
|
1.38 units on a scale
Standard Deviation 0.22
|
1.35 units on a scale
Standard Deviation 0.24
|
1.41 units on a scale
Standard Deviation 0.24
|
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 |
Total Toothpaste
n=41 Participants
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).
|
Toothpaste + Mouthwash
n=42 Participants
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.
|
Control Group
n=41 Participants
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.
|
|---|---|---|---|
|
Gingivitis Scores
|
1.15 units on a scale
Standard Error 0.04
|
1.20 units on a scale
Standard Error 0.04
|
1.30 units on a scale
Standard Error 0.04
|
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 |
Total Toothpaste
n=41 Participants
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).
|
Toothpaste + Mouthwash
n=42 Participants
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.
|
Control Group
n=41 Participants
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.
|
|---|---|---|---|
|
Gingivitis Scores
|
1.05 units on a scale
Standard Error 0.04
|
1.15 units on a scale
Standard Error 0.04
|
1.24 units on a scale
Standard Error 0.04
|
Adverse Events
Total 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
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
Yiming Li, DDS
Loma Linda University School of Dentistry
Phone: 909-558-8069
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60