Investigate Plaque and Gingival Index

• Sponsor: Colgate Palmolive (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00762762
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Duration (Months): 33.1
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

Clinical research study to determine the anti-plaque efficacy of commerical dentifrices.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis	Drug: Triclosan and fluoride; Drug: Fluoride	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Investigate Plaque and Gingival Index
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A	Drug: Triclosan and fluoride; Brush twice daily; Other Names: triclosan/fluoride/copolymer toothpaste
Placebo Comparator: B	Drug: Fluoride; swished twice daily; Other Names: Anti-cavitiy fluoride oral rinse

Outcome Measures

Primary Outcome Measures

1. HbA1c Levels in Blood [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.

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.

3. C-Peptide [12 months]

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

4. IL-6 (Interleukin - 6) [12 months]

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

5. TNF-α (Tumor Necrosis Factor - Alpha) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Type 2 diabetes with poor glycaemic control as evidenced by random blood glucose of

200mg/dl.

• Minimum of 16 teeth

• Chronic periodontitis as indicated by periodontal probing depths >4mm on at least 6 teeth

Exclusion Criteria:

• Any condition requiring antibiotic cover for dental treatment

• Other serious illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Republic of Marshall Islands	Queensland		Australia

Sponsors and Collaborators

• Colgate Palmolive

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Colgate Palmolive
• ClinicalTrials.gov Identifier: NCT00762762
• Other Study ID Numbers: 2004000685
• First Posted: Sep 30, 2008
• Last Update Posted: Apr 26, 2012
• Last Verified: Apr 1, 2012

• Additional relevant MeSH terms: Periodontitis; Triclosan; Fluorides

Study Results

Participant Flow

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

Arm/Group Title	Active Comparator	Placebo Comparator
Arm/Group Description	triclosan/fluoride/copolymer toothpaste	Anti-cavity, fluoride oral rinse
Period Title: Overall Study
STARTED	30	30
COMPLETED	22	20
NOT COMPLETED	8	10

Baseline Characteristics

Arm/Group Title	Active Comparator	Placebo Comparator	Total
Arm/Group Description	triclosan/fluoride/copolymer toothpaste	Anti-cavity, fluoride oral rinse	Total of all reporting groups
Overall Participants	30	30	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	30 100%	30 100%	60 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.6 (7.5)	48.8 (8.7)	49.7 (8.1)
Sex: Female, Male (Count of Participants)
Female	13 43.3%	13 43.3%	26 43.3%
Male	17 56.7%	17 56.7%	34 56.7%
Region of Enrollment (participants) [Number]
Australia	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	HbA1c Levels in Blood
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Comparator	Placebo Comparator
Arm/Group Description	triclosan/fluoride/copolymer toothpaste	Anti-cavity, fluoride oral rinse
Measure Participants	30	30
Mean (Standard Deviation) [percentage of HbA1c levels]	11.42 (1.71)	10.81 (1.76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active Comparator, 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	ANOVA
	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Comparator	Placebo Comparator
Arm/Group Description	triclosan/fluoride/copolymer toothpaste	Anti-cavity, fluoride oral rinse
Measure Participants	30	30
Mean (Standard Deviation) [µg/ml]	14.94 (13.62)	10.76 (8.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active Comparator, 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	ANOVA
	Comments

3. Primary Outcome

Title	C-Peptide
Description	C-Peptide levels in blood indicate whether or not a person is producing insulin
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Comparator	Placebo Comparator
Arm/Group Description	triclosan/fluoride/copolymer toothpaste	Anti-cavity, fluoride oral rinse
Measure Participants	30	30
Mean (Standard Deviation) [ng/ml]	5.39 (3.68)	4.61 (2.70)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active Comparator, 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	ANOVA
	Comments

4. Primary Outcome

Title	IL-6 (Interleukin - 6)
Description	Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picagrams)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Comparator	Placebo Comparator
Arm/Group Description	triclosan/fluoride/copolymer toothpaste	Anti-cavity, fluoride oral rinse
Measure Participants	30	30
Mean (Standard Deviation) [pg/ml]	1.93 (1.44)	2.89 (3.01)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active Comparator, 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	ANOVA
	Comments

5. Primary Outcome

Title	TNF-α (Tumor Necrosis Factor - Alpha)
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Comparator	Placebo Comparator
Arm/Group Description	triclosan/fluoride/copolymer toothpaste	Anti-cavity, fluoride oral rinse
Measure Participants	30	30
Mean (Standard Deviation) [pg/ml]	4.13 (4.84)	3.50 (6.41)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active Comparator, 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	ANOVA
	Comments

Adverse Events

Time Frame	24 months (2 years)
Arm/Group Title	Active Comparator		Placebo Comparator
Arm/Group Description	triclosan/fluoride/copolymer toothpaste		Anti-cavity, fluoride oral rinse
All Cause Mortality
	Active Comparator		Placebo Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Active Comparator		Placebo Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Active Comparator		Placebo Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (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.