MedDataX Logo

Trial Outcomes & Findings for Development of Clinical Method to Triclosan Retention in Plaque Following Brushing (NCT NCT00762853)

NCT ID: NCT00762853

Last Updated: 2012-02-17

Results Overview

Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

20 participants

Primary outcome timeframe

12 hours

Results posted on

2012-02-17

Participant Flow

subjects were recruited by the PI at the clinical site

Subjects were screened for medical and oral health criteria and then began a 1 week washout period with fluoride toothpaste.

Participant milestones

Participant milestones
Measure
Placebo First, Active Second
subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
Active Toothpaste First, Then Placebo
Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
First Treatment Period
STARTED
10
10
First Treatment Period
COMPLETED
10
10
First Treatment Period
NOT COMPLETED
0
0
1 Week Washout After Treatment 1
STARTED
10
10
1 Week Washout After Treatment 1
COMPLETED
10
10
1 Week Washout After Treatment 1
NOT COMPLETED
0
0
Second Treatment Period
STARTED
10
10
Second Treatment Period
COMPLETED
10
10
Second Treatment Period
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo First, Active Second
n=10 Participants
subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
Active Toothpaste First, Then Placebo
n=10 Participants
Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
Total
n=20 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
Age, Categorical
Between 18 and 65 years
10 Participants
n=5 Participants
10 Participants
n=7 Participants
20 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age Continuous
35.9 years
STANDARD_DEVIATION 11.9 • n=5 Participants
35.6 years
STANDARD_DEVIATION 9.9 • n=7 Participants
35.8 years
STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants
Region of Enrollment
Thailand
10 participants
n=5 Participants
10 participants
n=7 Participants
20 participants
n=5 Participants

PRIMARY outcome

Timeframe: 12 hours

Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.

Outcome measures

Outcome measures
Measure
Fluoride Toothpaste (Placebo)
n=20 Participants
fluoride only toothpaste
Active Toothpaste
n=20 Participants
fluoride/triclosan/copolymer(Active) toothpaste
Triclosan Concentration in Dental Plaque
0 ppm levels of triclosan
Standard Deviation 0
1.8 ppm levels of triclosan
Standard Deviation 1.2

Adverse Events

Placebo First, Active Second

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Active Toothpaste First, Then Placebo

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

William Devizio

Colgate Palmolive Co.

Phone: 732-878-7901

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60