Trial Outcomes & Findings for Effectiveness of a Triclosan Containing Toothpaste in Maintaining Periodontal Health in a Type 2 Diabetic Population (NCT NCT00762762)

NCT ID: NCT00762762

Last Updated: 2023-03-03

Results Overview

Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 60 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2023-03-03

Participant Flow

all subjects were recruited by the PI at the clinical site.

all subjects pass a medical exam and meet the study inclusion/exclusion criteria.

Participant milestones

Measure	Active Comparator triclosan/fluoride/copolymer toothpaste	Placebo Comparator Anti-cavity, fluoride oral rinse
Overall Study STARTED	30	30
Overall Study COMPLETED	24	22
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal

Measure	Active Comparator triclosan/fluoride/copolymer toothpaste	Placebo Comparator Anti-cavity, fluoride oral rinse
Overall Study Did not return for appointments	6	8

Baseline Characteristics

Effectiveness of a Triclosan Containing Toothpaste in Maintaining Periodontal Health in a Type 2 Diabetic Population

Baseline characteristics by cohort

Measure	Active Comparator n=30 Participants triclosan/fluoride/copolymer toothpaste	Placebo Comparator n=30 Participants Anti-cavity, fluoride oral rinse	Total n=60 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	30 Participants n=5 Participants	30 Participants n=7 Participants	60 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	50.6 years STANDARD_DEVIATION 7.5 • n=5 Participants	48.8 years STANDARD_DEVIATION 8.7 • n=7 Participants	49.7 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment Australia	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood.

Outcome measures

Measure	Triclosan/Copolymer/Fluoride Toothpaste n=30 Participants Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Triclosan/copolymer/fluoride: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.	Fluoride Mouthrinse n=30 Participants Swish whole mouth 2x/day for 12 months with fluoride mouthrinse. Fluoride: Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
HbA1c Levels in Blood	11.42 percentage of HbA1c levels in blood Standard Deviation 1.71	10.81 percentage of HbA1c levels in blood Standard Deviation 1.76

PRIMARY outcome

Timeframe: 12 months

CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease.

Outcome measures

Measure	Triclosan/Copolymer/Fluoride Toothpaste n=30 Participants Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Triclosan/copolymer/fluoride: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.	Fluoride Mouthrinse n=30 Participants Swish whole mouth 2x/day for 12 months with fluoride mouthrinse. Fluoride: Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
High Sensitivity CRP (C-Reactive Protein)	14.94 µg/ml Standard Deviation 13.62	10.76 µg/ml Standard Deviation 8.51

PRIMARY outcome

Timeframe: 12 months

C-Peptide levels in blood indicate whether or not a person is producing insulin

Outcome measures

Measure	Triclosan/Copolymer/Fluoride Toothpaste n=30 Participants Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Triclosan/copolymer/fluoride: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.	Fluoride Mouthrinse n=30 Participants Swish whole mouth 2x/day for 12 months with fluoride mouthrinse. Fluoride: Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
C-Peptide	5.39 ng/ml Standard Deviation 3.68	4.61 ng/ml Standard Deviation 0.83

PRIMARY outcome

Timeframe: 12 months

Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picograms)

Outcome measures

Measure	Triclosan/Copolymer/Fluoride Toothpaste n=30 Participants Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Triclosan/copolymer/fluoride: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.	Fluoride Mouthrinse n=30 Participants Swish whole mouth 2x/day for 12 months with fluoride mouthrinse. Fluoride: Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
IL-6 (Interleukin - 6)	1.93 pg/ml Standard Deviation 1.44	2.89 pg/ml Standard Deviation 3.01

PRIMARY outcome

Timeframe: 12 months

Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation.

Outcome measures

Measure	Triclosan/Copolymer/Fluoride Toothpaste n=30 Participants Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Triclosan/copolymer/fluoride: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.	Fluoride Mouthrinse n=30 Participants Swish whole mouth 2x/day for 12 months with fluoride mouthrinse. Fluoride: Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
TNF-α (Tumor Necrosis Factor - Alpha)	4.13 pg/ml Standard Deviation 4.84	3.50 pg/ml Standard Deviation 6.41

PRIMARY outcome

Timeframe: 12 months

CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease.

Outcome measures

Measure	Triclosan/Copolymer/Fluoride Toothpaste n=24 Participants Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Triclosan/copolymer/fluoride: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.	Fluoride Mouthrinse n=22 Participants Swish whole mouth 2x/day for 12 months with fluoride mouthrinse. Fluoride: Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
High Sensitivity CRP (C-Reactive Protein)	14.94 µg/ml Standard Deviation 13.62	10.76 µg/ml Standard Deviation 8.51

PRIMARY outcome

Timeframe: 12 months

Population: Fourteen (14) participants did not report for 1 year clinical appointment. Lost to follow up.

Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood.

Outcome measures

Measure	Triclosan/Copolymer/Fluoride Toothpaste n=24 Participants Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Triclosan/copolymer/fluoride: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.	Fluoride Mouthrinse n=22 Participants Swish whole mouth 2x/day for 12 months with fluoride mouthrinse. Fluoride: Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
HbA1c Levels in Blood	11.42 percentage of HbA1c levels Standard Deviation 1.71	10.81 percentage of HbA1c levels Standard Deviation 1.76

PRIMARY outcome

Timeframe: 12 months

C-Peptide levels in blood indicate whether or not a person is producing insulin

Outcome measures

Measure	Triclosan/Copolymer/Fluoride Toothpaste n=24 Participants Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Triclosan/copolymer/fluoride: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.	Fluoride Mouthrinse n=22 Participants Swish whole mouth 2x/day for 12 months with fluoride mouthrinse. Fluoride: Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
C-Peptide	5.39 ng/ml Standard Deviation 3.68	4.61 ng/ml Standard Deviation 2.70

PRIMARY outcome

Timeframe: 12 months

Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picograms)

Outcome measures

Measure	Triclosan/Copolymer/Fluoride Toothpaste n=24 Participants Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Triclosan/copolymer/fluoride: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.	Fluoride Mouthrinse n=22 Participants Swish whole mouth 2x/day for 12 months with fluoride mouthrinse. Fluoride: Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
IL-6 (Interleukin - 6)	1.93 pg/ml Standard Deviation 1.44	2.89 pg/ml Standard Deviation 3.01

PRIMARY outcome

Timeframe: 12 months

Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation.

Outcome measures

Measure	Triclosan/Copolymer/Fluoride Toothpaste n=24 Participants Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Triclosan/copolymer/fluoride: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.	Fluoride Mouthrinse n=22 Participants Swish whole mouth 2x/day for 12 months with fluoride mouthrinse. Fluoride: Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
TNF-α (Tumor Necrosis Factor - Alpha)	4.13 pg/ml Standard Deviation 4.84	3.50 pg/ml Standard Deviation 6.41

Adverse Events

Active Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo 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, DMD

Colgate Palmolive Co.

Phone: 732-878-7901

Email: william_devizio@colpal.com

Results disclosure agreements

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

Restriction type: LTE60