Trial Outcomes & Findings for Compare Anti-inflammatory Dentifrices (NCT NCT00762528)

Results Overview

Gingival Index(GI)recorded on scale of 0-3 detailed below: 0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration \& tendency to spontaneously bleed

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

49 participants

Primary outcome timeframe

29 days

Results posted on

2015-09-10

Participant Flow

subject recruitment will be completed by the PI at the clinical site.

Subjects are screened for plaque, bleeding and gingivitis scores before being assigned to any Study Treatment. Study Treatment randomization is balanced across the two treatment groups and is accomplished by stratification of subjects by gender (male \& female) and baseline gingivitis (GI) scores.

Participant milestones

Participant milestones
Measure	Total Toothpaste Triclosan/Copolymer/fluoride toothpaste	Fluoride Toothpaste Sodium monofluorophosphate toothpaste
Overall Study STARTED	24	25
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Compare Anti-inflammatory Dentifrices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Toothpaste n=24 Participants Triclosan/Copolymer/fluoride toothpaste	Fluoride Toothpaste n=25 Participants sodium monofluorophosphate toothpaste	Total n=49 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	24 Participants n=5 Participants	25 Participants n=7 Participants	49 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	27.5 years STANDARD_DEVIATION 10.7 • n=5 Participants	29.2 years STANDARD_DEVIATION 9.6 • n=7 Participants	28.4 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	25 participants n=7 Participants	49 participants n=5 Participants

PRIMARY outcome

Timeframe: 29 days

Gingival Index(GI)recorded on scale of 0-3 detailed below: 0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration \& tendency to spontaneously bleed

Outcome measures

Outcome measures
Measure	Total Toothpaste n=24 Participants Triclosan/Copolymer/fluoride toothpaste	Fluoride Toothpaste n=25 Participants sodium monofluorophosphate toothpaste
Gingival Index (GI)	1.04 units on a scale Standard Deviation 0.22	1.01 units on a scale Standard Deviation 0.19

PRIMARY outcome

Timeframe: 29 days

Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.

Outcome measures

Outcome measures
Measure	Total Toothpaste n=24 Participants Triclosan/Copolymer/fluoride toothpaste	Fluoride Toothpaste n=25 Participants sodium monofluorophosphate toothpaste
Prostaglandin E2 (PGE2)	5.8 pg/µl Standard Deviation 2.7	5.2 pg/µl Standard Deviation 3

PRIMARY outcome

Timeframe: 29 days

Inflammatory biomarkers found in gingival crevicular fluid (GCF) that may be a factor in oral tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.

Outcome measures

Outcome measures
Measure	Total Toothpaste n=24 Participants Triclosan/Copolymer/fluoride toothpaste	Fluoride Toothpaste n=25 Participants sodium monofluorophosphate toothpaste
Interleukin - 1 Beta (IL-ß)	6.9 pg/µl Standard Deviation 0.8	6.6 pg/µl Standard Deviation 1.2

PRIMARY outcome

Timeframe: 29 days

Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.

Outcome measures

Outcome measures
Measure	Total Toothpaste n=24 Participants Triclosan/Copolymer/fluoride toothpaste	Fluoride Toothpaste n=25 Participants sodium monofluorophosphate toothpaste
Interleukin-6 (IL-6)	2.8 pg/µl Standard Deviation 0.7	2.7 pg/µl Standard Deviation 0.6

PRIMARY outcome

Timeframe: 29 days

Receptor activator found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.

Outcome measures

Outcome measures
Measure	Total Toothpaste n=24 Participants Triclosan/Copolymer/fluoride toothpaste	Fluoride Toothpaste n=25 Participants sodium monofluorophosphate toothpaste
Nuclear Factor Kappa B Ligand (RANK-L)	4.5 pg/µl Standard Deviation 0.9	4.4 pg/µl Standard Deviation 1

PRIMARY outcome

Timeframe: 29 days

Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.

Outcome measures

Outcome measures
Measure	Total Toothpaste n=24 Participants Triclosan/Copolymer/fluoride toothpaste	Fluoride Toothpaste n=25 Participants sodium monofluorophosphate toothpaste
8-iso-prostaglandinF2α (8-iso-PGF2α)	14.2 pg/µl Standard Deviation 3.8	15.2 pg/µl Standard Deviation 1.6

SECONDARY outcome

Timeframe: 29 days

measurement of supragingival dental plaque on scale of 0-3. 0=No plaque in gingival area,1=a film of plaque adhering to the free gingival margin and the adjacent tooth,2=Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth-visible by the naked eye, 3=Abundance of soft matter within the gingival pocket and/or gingival margin and adjacent tooth surfaces.

Outcome measures

Outcome measures
Measure	Total Toothpaste n=24 Participants Triclosan/Copolymer/fluoride toothpaste	Fluoride Toothpaste n=25 Participants sodium monofluorophosphate toothpaste
Dental Plaque Index (PI)	1.69 Units on a scale Standard Deviation 0.30	1.65 Units on a scale Standard Deviation 0.35

SECONDARY outcome

Timeframe: 29 days

Presence or absence of bleeding to manual probing as a dichotomous variable as follows: 0 = No bleeding within 10 seconds after probing, 1 = Bleeding within 10 seconds after probing.

Outcome measures

Outcome measures
Measure	Total Toothpaste n=24 Participants Triclosan/Copolymer/fluoride toothpaste	Fluoride Toothpaste n=25 Participants sodium monofluorophosphate toothpaste
Bleeding on Probing (BOP)	0.24 Units on a scale Standard Deviation 0.10	0.26 Units on a scale Standard Deviation 0.12

Adverse Events

Total Toothpaste

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Fluoride Toothpaste

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Total Toothpaste n=24 participants at risk Triclosan/Copolymer/fluoride toothpaste	Fluoride Toothpaste n=25 participants at risk sodium monofluorophosphate toothpaste
General disorders Teeth Sensitive to cold	0.00% 0/24 • 29 days	8.0% 2/25 • Number of events 2 • 29 days
General disorders Oral Irritation	0.00% 0/24 • 29 days	4.0% 1/25 • Number of events 1 • 29 days
General disorders chest cold, upper respiratory infection	4.2% 1/24 • Number of events 1 • 29 days	4.0% 1/25 • Number of events 1 • 29 days
General disorders Pulled muscle in back	0.00% 0/24 • 29 days	4.0% 1/25 • Number of events 1 • 29 days
General disorders Fever, chills & sore throat	0.00% 0/24 • 29 days	4.0% 1/25 • Number of events 1 • 29 days

Additional Information

William DeVizio, DMD

Colgate Palmolive Company

Phone: 732-878-7901

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60