Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse

• Sponsor: Colgate Palmolive (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01024738
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 3
• Duration (Months): 1
• Patients Per Site Per Month: 21.6

Study Details

Study Description

Brief Summary

Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse

Condition or Disease	Intervention/Treatment	Phase
Dental Plaque	Drug: Fluoride; Drug: Triclosan, fluoride; Drug: Chlorhexidine Gluconate	Phase 3

Detailed Description

Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Fluoride toothpaste negative control toothpaste	Drug: Fluoride; Brush half mouth twice daily for four days.
Active Comparator: Triclosan/Fluoride toothpaste positive control toothpaste (Total toothpaste)	Drug: Triclosan, fluoride; Brush twice daily; Other Names: Total toothpaste
Active Comparator: Chlorhexidine Oral Rinse positive control oral rinse	Drug: Chlorhexidine Gluconate; Rinse mouth twice a day

Outcome Measures

Primary Outcome Measures

1. Plaque Index [4 Days]

   Plaque score is Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Be aged 18 to 65 years inclusive

• Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present

• Give written informed consent

• Be in good general health

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

• If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)

Exclusion Criteria:

• Medical condition which requires pre-medication (antibiotics) prior to dental

• Visits/procedures

• Allergy to chlorhexidine

• Advanced periodontal disease (gum disease)

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

• Diseases of the soft or hard oral tissues (gums or palate)

• Orthodontic appliances that interfere with plaque rating

• Abnormal salivary function

• Use of drugs that can affect currently salivary flow or production

• 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)

• Pregnant or breastfeeding.

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

• Allergic to common toothpaste or mouth rinse ingredients.

• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TKL Research, Inc.	Paramus	New Jersey	United States	07652

Sponsors and Collaborators

• Colgate Palmolive

Investigators

• Principal Investigator: Mark LeFelt, DDS,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01024738
• Other Study ID Numbers: CRO-2008-PLA-05-RR
• First Posted: Dec 3, 2009
• Last Update Posted: Dec 3, 2009
• Last Verified: Oct 1, 2009

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

Study Results

Participant Flow

Recruitment Details	Performed at the clinic

Arm/Group Title	Fluoride Toothpaste First	Triclosan/Fluoride Toothpaste First	Chlorhexidine Oral Rinse
Arm/Group Description	Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last	triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last	chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
Period Title: First Intervention:
STARTED	7	7	8
COMPLETED	7	7	8
NOT COMPLETED	0	0	0
Period Title: First Intervention:
STARTED	7	7	8
COMPLETED	7	7	8
NOT COMPLETED	0	0	0
Period Title: First Intervention:
STARTED	7	7	8
COMPLETED	7	7	8
NOT COMPLETED	0	0	0
Period Title: First Intervention:
STARTED	7	7	8
COMPLETED	7	7	8
NOT COMPLETED	0	0	0
Period Title: First Intervention:
STARTED	7	7	8
COMPLETED	7	7	8
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Fluoride Toothpaste	Total Toothpaste	Chlorhexidine Oral Rinse	Total
Arm/Group Description	negative control toothpaste	triclosan/fluoride toothpaste (positive control)	chlorhexidine oral rinse (positive control)	Total of all reporting groups
Overall Participants	7	7	8	22
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	7 100%	7 100%	8 100%	22 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.2 (10.23)	50.5 (6.5)	56.6 (5.5)	50.43 (8.86)
Sex: Female, Male (Count of Participants)
Female	7 100%	6 85.7%	7 87.5%	20 90.9%
Male	0 0%	1 14.3%	1 12.5%	2 9.1%
Region of Enrollment (participants) [Number]
United States	7 100%	7 100%	8 100%	22 100%

Outcome Measures

1. Primary Outcome

Title	Plaque Index
Description	Plaque score is Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Time Frame	4 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluoride Toothpaste	Total Toothpaste	Chlorhexidine Oral Rinse
Arm/Group Description	negative control toothpaste	triclosan/fluoride toothpaste (positive control)	chlorhexidine oral rinse (positive control)
Measure Participants	22	22	22
Mean (Standard Deviation) [Units on a scale]	3.31 (0.48)	3.31 (0.38)	2.91 (0.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fluoride Toothpaste, Total Toothpaste, Chlorhexidine Oral Rinse
	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	2 month test period
Adverse Event Reporting Description	subjects used the product twice a day for 4 days with oral exams at beginning and end of treatment periods.
Arm/Group Title	Fluoride Toothpaste First		Triclosan/Fluoride Toothpaste First		Chlorhexidine Oral Rinse
Arm/Group Description	Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last		triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last		chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
All Cause Mortality
	Fluoride Toothpaste First		Triclosan/Fluoride Toothpaste First		Chlorhexidine Oral Rinse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Fluoride Toothpaste First		Triclosan/Fluoride Toothpaste First		Chlorhexidine Oral Rinse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Fluoride Toothpaste First		Triclosan/Fluoride Toothpaste First		Chlorhexidine Oral Rinse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)		1/22 (4.5%)
Social circumstances
Non related adverse event	0/22 (0%)	0	0/22 (0%)	0	1/22 (4.5%)	1

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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.