Trial Outcomes & Findings for Effect on Bacterial Glycolytic Acid Formation on Plaque (NCT NCT00762450)
NCT ID: NCT00762450
Last Updated: 2012-03-07
Results Overview
Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
6 participants
Primary outcome timeframe
1 week
Results posted on
2012-03-07
Participant Flow
subjects are recruited by the PI at the clinical site
subjects are screened for medical and oral health criteria and start a 1 week washout period.
Participant milestones
| Measure |
Placebo 1st, Active Comparator 2nd and Experimental Last
Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
|
Active Comparator 1st, Experimental 2nd and Placebo Last
Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
|
Experimental 1st, Placebo 2nd and Active Comparator Last
Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
|
|---|---|---|---|
|
1st Treatment Period
STARTED
|
2
|
2
|
2
|
|
1st Treatment Period
COMPLETED
|
2
|
2
|
2
|
|
1st Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout After 1st Treatment Period
STARTED
|
2
|
2
|
2
|
|
Washout After 1st Treatment Period
COMPLETED
|
2
|
2
|
2
|
|
Washout After 1st Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
|
2nd Treatment Period
STARTED
|
2
|
2
|
2
|
|
2nd Treatment Period
COMPLETED
|
2
|
2
|
2
|
|
2nd Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout After 2nd Treatment Period
STARTED
|
2
|
2
|
2
|
|
Washout After 2nd Treatment Period
COMPLETED
|
2
|
2
|
2
|
|
Washout After 2nd Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
|
3rd Treatment Period
STARTED
|
2
|
2
|
2
|
|
3rd Treatment Period
COMPLETED
|
2
|
2
|
2
|
|
3rd Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect on Bacterial Glycolytic Acid Formation on Plaque
Baseline characteristics by cohort
| Measure |
Placebo First, Positive Control Second and Experimental Last
n=2 Participants
|
Positive Control First, Experimental Second and Placebo Last
n=2 Participants
|
Experimental First, Placebo Second and Positive Control Last
n=2 Participants
|
Total
n=6 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age Continuous
|
76.5 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
77.5 years
STANDARD_DEVIATION 0.7 • n=7 Participants
|
73.5 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
75.8 years
STANDARD_DEVIATION 2.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Switzerland
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 weekPanelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth.
Outcome measures
| Measure |
Active Comparator
n=6 Participants
|
Placebo - Silica Control
n=6 Participants
|
Experimental Toothpaste
n=6 Participants
|
|---|---|---|---|
|
ph of Dental Plaque After Sucrose Challenge
|
4.88 ph of dental plaque
Standard Deviation 0.38
|
5.04 ph of dental plaque
Standard Deviation 0.38
|
4.98 ph of dental plaque
Standard Deviation 0.24
|
Adverse Events
Placebo First, Positive Control Second and Experimental Last
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Positive Control First, Experimental Second and Placebo Last
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental First, Placebo Second and Positive Control Last
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: LTE60