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

• Sponsor: Colgate Palmolive (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00763256
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

To test effectiveness of dentifrice in maintaining periodontal health.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Disease	Drug: Triclosan, Fluoride; Drug: Fluoride	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A	Drug: Triclosan, Fluoride; subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.; Other Names: triclosan/fluoride/copolymer toothpaste
Placebo Comparator: B	Drug: Fluoride; subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.; Other Names: current marketed fluoride only toothpaste

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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).

3. 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).

4. 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)

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Logan Hospital Oral Health Clinic	Queensland		Australia

Sponsors and Collaborators

• Colgate Palmolive

Investigators

• Principal Investigator: Gregory Seymour, BDS, University of Otago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Colgate Palmolive
• ClinicalTrials.gov Identifier: NCT00763256
• Other Study ID Numbers: 2004000841/2004/201
• First Posted: Sep 30, 2008
• Last Update Posted: Jul 28, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Periodontal Diseases; Triclosan; Fluorides

Study Results

Participant Flow

Recruitment Details	all subjects were recruited at the clinical site by the PI.
Pre-assignment Detail	All subjects passed a medical exam and met the inclusion/exclusion criteria.

Arm/Group Title	Active Comparator	B - Placebo Comparator
Arm/Group Description	triclosan/fluoride/copolymer toothpaste	fluoride only toothpaste
Period Title: Overall Study
STARTED	15	18
COMPLETED	8	8
NOT COMPLETED	7	10

Baseline Characteristics

Arm/Group Title	Active Comparator	B - Placebo Comparator	Total
Arm/Group Description	triclosan/fluoride/copolymer toothpaste	fluoride only toothpaste	Total of all reporting groups
Overall Participants	15	18	33
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	14 93.3%	16 88.9%	30 90.9%
>=65 years	1 6.7%	2 11.1%	3 9.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (7.6)	49 (11)	51 (9.5)
Sex: Female, Male (Count of Participants)
Female	5 33.3%	9 50%	14 42.4%
Male	10 66.7%	9 50%	19 57.6%
Region of Enrollment (participants) [Number]
Australia	15 100%	18 100%	33 100%

Outcome Measures

1. Primary Outcome

Title	HbA1c Levels in Blood
Description	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).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Comparator	B - Placebo Comparator
Arm/Group Description	triclosan/fluoride/copolymer toothpaste	fluoride only toothpaste
Measure Participants	15	18
Mean (Standard Deviation) [Percentage]	9.47 (2.2)	10.27 (2.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active Comparator, B - Placebo Comparator
	Comments	The null hypothesis states that there is no difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	High Sensitivity CRP (C-Reactive Protein)
Description	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).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Comparator	B - Placebo Comparator
Arm/Group Description	triclosan/fluoride/copolymer toothpaste	fluoride only toothpaste
Measure Participants	15	18
Mean (Standard Deviation) [mg/L]	6.16 (5.5)	5.37 (3.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active Comparator, B - Placebo Comparator
	Comments	The null hypothesis states that there is no difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 2 sided
	Comments

3. Primary Outcome

Title	C-Peptide
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Comparator	B - Placebo Comparator
Arm/Group Description	triclosan/fluoride/copolymer toothpaste	fluoride only toothpaste
Measure Participants	15	18
Mean (Standard Deviation) [nmol/L]	1.20 (1.0)	1.04 (0.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active Comparator, B - Placebo Comparator
	Comments	The null hypothesis states that there is no difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 2 sided
	Comments

4. Primary Outcome

Title	Gingivitis Score (GI)
Description	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)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Comparator	B - Placebo Comparator
Arm/Group Description	triclosan/fluoride/copolymer toothpaste	fluoride only toothpaste
Measure Participants	15	18
Mean (Standard Deviation) [Units on a scale]	0.89 (0.2)	0.88 (0.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active Comparator, B - Placebo Comparator
	Comments	The null hypothesis states that there is no difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 2 sided
	Comments

5. Primary Outcome

Title	P. Gingivalis
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Comparator	B - Placebo Comparator
Arm/Group Description	triclosan/fluoride/copolymer toothpaste	fluoride only toothpaste
Measure Participants	15	18
Median (Inter-Quartile Range) [Pg/ng DNA]	209	22

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active Comparator, B - Placebo Comparator
	Comments	The null hypothesis states that there is no difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	12 months
Arm/Group Title	Active Comparator		B - Placebo Comparator
Arm/Group Description	triclosan/fluoride/copolymer toothpaste		fluoride only toothpaste
All Cause Mortality
	Active Comparator		B - Placebo Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Active Comparator		B - Placebo Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Active Comparator		B - Placebo Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.