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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00763256

Enrollment

Registered

2008-09-30

Start date

2006-05-31

Completion date

2009-08-31

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Disease

Brief summary

To test effectiveness of dentifrice in maintaining periodontal health.

Interventions

DRUGTriclosan, Fluoride

subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.

DRUGFluoride

subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* Poor glycaemic control as evidenced by an HbA1c of \>6.0% for the past 12 months * Aged 18 to 75 years * Able to give informed consent * Minimum of 12 teeth * Chronic periodontitis as indicated by periodontal probing depths \>5mm on at least 6 teeth

Exclusion criteria

* Pregnancy * Gross dental caries * Prosthetic heart valves, a history of infective endocarditis or any other condition requiring antibiotic cover for dental treatment (rheumatic fever, mitral valve prolapse with regurgitation) * Anticoagulant therapy (excluding asprin)

Design outcomes

Primary

Measure	Time frame	Description
HbA1c Levels in Blood	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).
High Sensitivity CRP (C-Reactive Protein)	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).
C-Peptide	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).
Gingivitis Score (GI)	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)
P. Gingivalis	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.

Countries

Australia

Participant flow

Recruitment details

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

Pre-assignment details

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

Participants by arm

Arm	Count
Active Comparator triclosan/fluoride/copolymer toothpaste	15
B - Placebo Comparator fluoride only toothpaste	18
Total	33

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Didn't return for appointments	7	10

Baseline characteristics

Characteristic	Active Comparator	B - Placebo Comparator	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	2 Participants	3 Participants
Age, Categorical Between 18 and 65 years	14 Participants	16 Participants	30 Participants
Age, Continuous	53 years STANDARD_DEVIATION 7.6	49 years STANDARD_DEVIATION 11	51 years STANDARD_DEVIATION 9.5
Region of Enrollment Australia	15 participants	18 participants	33 participants
Sex: Female, Male Female	5 Participants	9 Participants	14 Participants
Sex: Female, Male Male	10 Participants	9 Participants	19 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 15	0 / 18
serious Total, serious adverse events	0 / 15	0 / 18

Outcome results

Primary

C-Peptide

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).

Time frame: 12 months

Arm	Measure	Value (MEAN)	Dispersion
Active Comparator	C-Peptide	1.20 nmol/L	Standard Deviation 1
B - Placebo Comparator	C-Peptide	1.04 nmol/L	Standard Deviation 0.6