Evaluating Commercial Anti-Plaque Products and Oral Rinse

• Sponsor: Colgate Palmolive (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01014143
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 3
• Duration (Months): 1
• Patients Per Site Per Month: 25.5

Study Details

Study Description

Brief Summary

Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.

Condition or Disease	Intervention/Treatment	Phase
Dental Plaque	Drug: Fluoride; Drug: Chlorhexidine digluconate; Drug: Fluoride, triclosan	Phase 2

Detailed Description

This clinical research study was to train new examiners for short term plaque clinical methodologies.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluating Commercial Anti-Plaque Products and Oral Rinse
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Sep 1, 2007
• Actual Study Completion Date: Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Fluoride toothpaste Negative control	Drug: Fluoride; Half mouth toothbrushing twice a day for four days.; Other Names: fluoride toothpaste
Active Comparator: Triclosan/Fluoride toothpaste positive control toothpaste	Drug: Fluoride, triclosan; Half mouth Brushing twice daily; Other Names: Total toothpaste
Active Comparator: Chlorhexidine Oral Rinse Positive Control mouthrinse	Drug: Chlorhexidine digluconate; Mouth rinsing with 15 ml for 30 seconds twice a day for four days.; Other Names: Periogard oral rinse

Outcome Measures

Primary Outcome Measures

1. Plaque Index [Four days]

   Plaque 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: 23 Years to 81 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female volunteers at least 18 years of age.

• Good general health.

• Must sign informed consent form.

• Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.

• No 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:

• Subjects unable or unwilling to sign the informed consent form.

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

• Moderate or advanced periodontal disease or heavy dental tartar (calculus).

• Two or more decayed untreated dental sites at screening.

• Other disease of the hard or soft oral tissues.

• Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).

• Use of medications that are currently affect salivary function.

• Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.

• Allergy to chlorhexidine.

• Pregnant or nursing women.

• Participation in any other clinical study within 1 week prior to enrollment into this study.

• Use of tobacco products.

• Subjects who must receive dental treatment during the study dates.

• Current use of Antibiotics for pre-medication for dental treatment or for any other purpose.

• Presence of an orthodontic appliance that interferes with plaque scoring.

• History of allergy to common dentifrice ingredients.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Institutional Service Company	Northfield	New Jersey	United States	08225

Sponsors and Collaborators

• Colgate Palmolive

Investigators

• Principal Investigator: Matthew Cronin, DDS,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01014143
• Other Study ID Numbers: CRO-2007-PLA-15-RR
• First Posted: Nov 16, 2009
• Last Update Posted: Jun 14, 2011
• Last Verified: Jun 1, 2011

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

Study Results

Participant Flow

Recruitment Details	Recruitment was performed by the clinical site

Arm/Group Title	Fluoride Toothpaste First	Total Toothpaste First	Chlorhexidine Oral Rinse First
Arm/Group Description	Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last	triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last	chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
Period Title: First Intervention
STARTED	10	9	9
COMPLETED	10	9	9
NOT COMPLETED	0	0	0
Period Title: First Intervention
STARTED	10	9	9
COMPLETED	10	9	9
NOT COMPLETED	0	0	0
Period Title: First Intervention
STARTED	10	9	9
COMPLETED	8	9	9
NOT COMPLETED	2	0	0
Period Title: First Intervention
STARTED	8	9	9
COMPLETED	8	9	9
NOT COMPLETED	0	0	0
Period Title: First Intervention
STARTED	8	9	9
COMPLETED	8	9	9
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Fluoride Toothpaste	Total Toothpaste	Chlorhexidine Oral Rinse	Total
Arm/Group Description	negative control	triclosan/fluoride toothpaste (positive control toothpaste)	chlorhexidine mouthrinse (positive control rinse)	Total of all reporting groups
Overall Participants	10	9	9	28
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	9 100%	9 100%	28 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.6 (15.1)	39 (9.2)	47.2 (9.6)	44.5 (11.7)
Sex: Female, Male (Count of Participants)
Female	7 70%	6 66.7%	9 100%	22 78.6%
Male	3 30%	3 33.3%	0 0%	6 21.4%
Region of Enrollment (participants) [Number]
United States	10 100%	9 100%	9 100%	28 100%

Outcome Measures

1. Primary Outcome

Title	Plaque Index
Description	Plaque 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	Four days

Outcome Measure Data

Analysis Population Description

per protocol. 2 subjects missed appointments and did not complete two of the study treatment periods.

Arm/Group Title	Fluoride Toothpaste	Total Toothpaste	Chlorhexidine Oral Rinse
Arm/Group Description	negative control	triclosan/fluoride toothpaste (positive control toothpaste)	chlorhexidine mouthrinse (positive control rinse)
Measure Participants	28	26	26
Mean (Standard Deviation) [Units on a scale]	2.63 (0.61)	2.65 (0.56)	1.23 (0.59)

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	6 weeks
Adverse Event Reporting Description	subjects were examined at each clinic visit for any signs of side effects while using the study products. If any subject developed any potential side effect while using the study products, they called 24 hour contact number to report it and made an appointment with the clinician to have the side effect evaluated.
Arm/Group Title	Fluoride Toothpaste First		Total Toothpaste First		Chlorhexidine Oral Rinse First
Arm/Group Description	Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last		triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last		chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
All Cause Mortality
	Fluoride Toothpaste First		Total Toothpaste First		Chlorhexidine Oral Rinse First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Fluoride Toothpaste First		Total Toothpaste First		Chlorhexidine Oral Rinse First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Fluoride Toothpaste First		Total Toothpaste First		Chlorhexidine Oral Rinse First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/28 (3.6%)		1/28 (3.6%)		1/28 (3.6%)
Social circumstances
Upset stomach - non related to product use	1/26 (3.8%)	1	0/26 (0%)	0	0/26 (0%)	0
Sinus headache - non related to product use	0/26 (0%)	0	1/26 (3.8%)	1	0/26 (0%)	0
Menstrual cramps	0/26 (0%)	0	0/26 (0%)	0	1/26 (3.8%)	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.