Trial Outcomes & Findings for The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics (NCT NCT00763256)

Results Overview

Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

33 participants

Primary outcome timeframe

12 months

Results posted on

2015-07-28

Participant Flow

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

All subjects passed a medical exam and met the inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure	Active Comparator triclosan/fluoride/copolymer toothpaste	B - Placebo Comparator fluoride only toothpaste
Overall Study STARTED	15	18
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	7	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Comparator triclosan/fluoride/copolymer toothpaste	B - Placebo Comparator fluoride only toothpaste
Overall Study Didn't return for appointments	7	10

Baseline Characteristics

The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Comparator n=15 Participants triclosan/fluoride/copolymer toothpaste	B - Placebo Comparator n=18 Participants fluoride only toothpaste	Total n=33 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	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	53 years STANDARD_DEVIATION 7.6 • n=5 Participants	49 years STANDARD_DEVIATION 11 • n=7 Participants	51 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Australia	15 participants n=5 Participants	18 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).

Outcome measures

Outcome measures
Measure	Active Comparator n=15 Participants triclosan/fluoride/copolymer toothpaste	B - Placebo Comparator n=18 Participants fluoride only toothpaste
HbA1c Levels in Blood	9.47 Percentage Standard Deviation 2.2	10.27 Percentage Standard Deviation 2.4

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. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).

Outcome measures

Outcome measures
Measure	Active Comparator n=15 Participants triclosan/fluoride/copolymer toothpaste	B - Placebo Comparator n=18 Participants fluoride only toothpaste
High Sensitivity CRP (C-Reactive Protein)	6.16 mg/L Standard Deviation 5.5	5.37 mg/L Standard Deviation 3.8

PRIMARY outcome

Timeframe: 12 months

C-Peptide levels in blood indicate whether or not a person is producing insulin. This peptide is usually found in equal levels to insulin. C-peptide levels measured as a means of distinguishing type 1 diabetes and type 2 diabetes. Blood is taken from each subject and C-Peptide levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).

Outcome measures

Outcome measures
Measure	Active Comparator n=15 Participants triclosan/fluoride/copolymer toothpaste	B - Placebo Comparator n=18 Participants fluoride only toothpaste
C-Peptide	1.20 nmol/L Standard Deviation 1.0	1.04 nmol/L Standard Deviation 0.6

PRIMARY outcome

Timeframe: 12 months

Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)

Outcome measures

Outcome measures
Measure	Active Comparator n=15 Participants triclosan/fluoride/copolymer toothpaste	B - Placebo Comparator n=18 Participants fluoride only toothpaste
Gingivitis Score (GI)	0.89 Units on a scale Standard Deviation 0.2	0.88 Units on a scale Standard Deviation 0.1

PRIMARY outcome

Timeframe: 12 months

Subgingival plaque samples were collected from all interproximal (mesial) sites and pooled prior to assessment. The samples will be analysed for the presence of P. gingivalis, using real time PCR to quantitate the numbers of bacteria. P. gingivalis is a non-motile, gram negative, anaerobic, pathogenic bacteria. It is linked to periodontal disease and causes collagen degradation.

Outcome measures

Outcome measures
Measure	Active Comparator n=15 Participants triclosan/fluoride/copolymer toothpaste	B - Placebo Comparator n=18 Participants fluoride only toothpaste
P. Gingivalis	209 Pg/ng DNA Interval 0.0 to 23688.0	22 Pg/ng DNA Interval 0.0 to 15982.0

Adverse Events

Active Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B - 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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60