Trial Outcomes & Findings for Collection of Gingival Crevicular Fluid From Periodontitis Patients (NCT NCT00763048)

Results Overview

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

39 participants

Primary outcome timeframe

6 weeks

Results posted on

2011-06-14

Participant Flow

subjects were recruited by the PI at the clinical site

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

Participant milestones

Participant milestones
Measure	A - Control Comparator Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.	B - Active Comparator Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Overall Study STARTED	21	18
Overall Study COMPLETED	21	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Collection of Gingival Crevicular Fluid From Periodontitis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A - Control Comparator n=21 Participants Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.	B - Active Comparator n=18 Participants Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.	Total n=39 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	21 Participants n=5 Participants	18 Participants n=7 Participants	39 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	48 years STANDARD_DEVIATION 12.7 • n=5 Participants	49.8 years STANDARD_DEVIATION 12.8 • n=7 Participants	48.9 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	18 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.

Outcome measures

Outcome measures
Measure	A - Control Comparator n=21 Participants Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.	B - Active Comparator n=18 Participants Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Metabolite Associated With Inflammation (Cadaverine)	1.119186 ion count Standard Deviation 0.834969	0.92077 ion count Standard Deviation 0.78476

PRIMARY outcome

Timeframe: 6 weeks

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.

Outcome measures

Outcome measures
Measure	A - Control Comparator n=21 Participants Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.	B - Active Comparator n=18 Participants Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Metabolite Associated With Inflammation (Choline)	1.2264 ion count Standard Deviation 0.79066	1.169513 ion count Standard Deviation 0.79071

PRIMARY outcome

Timeframe: 6 weeks

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.

Outcome measures

Outcome measures
Measure	A - Control Comparator n=21 Participants Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.	B - Active Comparator n=18 Participants Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Metabolite Associated With Inflammation (Hypoxanthine)	0.76984 ion count Standard Deviation 0.58459	0.701628 ion count Standard Deviation 0.63887

PRIMARY outcome

Timeframe: 6 weeks

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.

Outcome measures

Outcome measures
Measure	A - Control Comparator n=21 Participants Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.	B - Active Comparator n=18 Participants Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Metabolite Associated With Inflammation (Inosine)	1.11183 ion count Standard Deviation 1.05685	0.84462 ion count Standard Deviation 0.99409

PRIMARY outcome

Timeframe: 6 weeks

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.

Outcome measures

Outcome measures
Measure	A - Control Comparator n=21 Participants Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.	B - Active Comparator n=18 Participants Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Metabolite Associated With Inflammation (Isoleucine)	1.20033 ion count Standard Deviation 0.61108	1.048449 ion count Standard Deviation 0.70947

PRIMARY outcome

Timeframe: 6 weeks

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.

Outcome measures

Outcome measures
Measure	A - Control Comparator n=21 Participants Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.	B - Active Comparator n=18 Participants Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Metabolite Associated With Inflammation (Leucine)	1.10064 ion count Standard Deviation 0.5424	1.018989 ion count Standard Deviation 0.64132

PRIMARY outcome

Timeframe: 6 weeks

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.

Outcome measures

Outcome measures
Measure	A - Control Comparator n=21 Participants Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.	B - Active Comparator n=18 Participants Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Metabolite Associated With Inflammation (Lysine)	1.063873 ion count Standard Deviation 0.785917	1.09704 ion count Standard Deviation 1.149168

PRIMARY outcome

Timeframe: 6 weeks

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.

Outcome measures

Outcome measures
Measure	A - Control Comparator n=21 Participants Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.	B - Active Comparator n=18 Participants Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Metabolite Associated With Inflammation (Phenylalanine)	1.16994 ion count Standard Deviation 0.56433	1.057373 ion count Standard Deviation 0.625110

PRIMARY outcome

Timeframe: 6 weeks

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.

Outcome measures

Outcome measures
Measure	A - Control Comparator n=21 Participants Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.	B - Active Comparator n=18 Participants Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Metabolite Associated With Inflammation (Putrescine)	1.050398 ion count Standard Deviation 0.69913	0.74134 ion count Standard Deviation 0.86837

PRIMARY outcome

Timeframe: 6 weeks

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present.Data is after 6 weeks use of the study treatment.

Outcome measures

Outcome measures
Measure	A - Control Comparator n=21 Participants Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.	B - Active Comparator n=18 Participants Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Metabolite Associated With Inflammation (Xanthine)	1.05189 ion count Standard Deviation 0.615226	1.011732 ion count Standard Deviation 0.96834

Adverse Events

A - Control Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B - Active Comparator

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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60