Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

• Sponsor: Colgate Palmolive (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00762853
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 19.6

Study Details

Study Description

Brief Summary

The objective is to develop a method to determine active ingredient uptake in oral care products.

Condition or Disease	Intervention/Treatment	Phase
Dental Plaque	Drug: Fluoride; Drug: Fluoride and triclosan	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Development of Clinical Method to Triclosan Retention in Plaque Following Brushing
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: A fluoride toothpaste from Thailand	Drug: Fluoride; Brush half mouth once with assigned study treatment
Active Comparator: B fluoride/triclosan/copolymer toothpaste	Drug: Fluoride and triclosan; Brush half mouth once with assigned study treatment; Other Names: Colgate Total toothpaste

Outcome Measures

Primary Outcome Measures

1. Triclosan Concentration in Dental Plaque [12 hours]

   Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Male or female volunteer 18 - 65 years of age (inclusive).

• Good general health with a minimum of twenty (20) natural, uncrowned teeth (excluding third molars)

• Able and willing to sign the informed consent form.

• Plaque score of at least 1.5 on the modified Quigley-Hein plaque index.

• No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

• Medical condition which requires pre-medication prior to dental procedures/visits

• Medical condition which precludes not eating/drinking for 2 hours

• Advanced periodontal disease (gum disease)

• 5 or more decayed, untreated dental sites (cavities)

• Diseases of the soft or hard oral tissues

• Orthodontic appliances

• Abnormal salivary function

• Use of drugs that can affect salivary flow

• Use of antibiotics one (1) month prior to or during this study

• Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxyn, etc)

• Pregnant or breastfeeding.

• Participation in another clinical study in the month preceding this study

• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mahidol University	Bangkok	Bangkok 10110	Thailand

Sponsors and Collaborators

• Colgate Palmolive

Investigators

• Principal Investigator: Terdphong Triantana, DDS,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00762853
• Other Study ID Numbers: CRO-2008-PLA-16-RR
• First Posted: Sep 30, 2008
• Last Update Posted: Feb 17, 2012
• Last Verified: Aug 1, 2010

• Additional relevant MeSH terms: Dental Plaque; Triclosan; Fluorides

Study Results

Participant Flow

Recruitment Details	subjects were recruited by the PI at the clinical site
Pre-assignment Detail	Subjects were screened for medical and oral health criteria and then began a 1 week washout period with fluoride toothpaste.

Arm/Group Title	Placebo First, Active Second	Active Toothpaste First, Then Placebo
Arm/Group Description	subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.	Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
Period Title: First Treatment Period
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0
Period Title: First Treatment Period
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0
Period Title: First Treatment Period
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Placebo First, Active Second	Active Toothpaste First, Then Placebo	Total
Arm/Group Description	subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.	Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	10 100%	20 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.9 (11.9)	35.6 (9.9)	35.8 (10.7)
Sex: Female, Male (Count of Participants)
Female	5 50%	5 50%	10 50%
Male	5 50%	5 50%	10 50%
Region of Enrollment (participants) [Number]
Thailand	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Triclosan Concentration in Dental Plaque
Description	Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.
Time Frame	12 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoride Toothpaste (Placebo)	Active Toothpaste
Arm/Group Description	fluoride only toothpaste	fluoride/triclosan/copolymer(Active) toothpaste
Measure Participants	20	20
Mean (Standard Deviation) [ppm levels of triclosan]	0 (0)	1.8 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fluoride Toothpaste (Placebo), Active Toothpaste
	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	ANCOVA
	Comments

Adverse Events

Time Frame	16 days
Arm/Group Title	Placebo First, Active Second		Active Toothpaste First, Then Placebo
Arm/Group Description	subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.		Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
All Cause Mortality
	Placebo First, Active Second		Active Toothpaste First, Then Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo First, Active Second		Active Toothpaste First, Then Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Placebo First, Active Second		Active Toothpaste First, Then Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (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.