Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes

• Sponsor: Colgate Palmolive (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00762515
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 7.4

Study Details

Study Description

Brief Summary

The objective is to compare two commerical oral products for the treatment of gingivitis.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: A commercially available Fluoride only toothpaste	Drug: Fluoride; Brush teeth two times daily for 6 weeks
Active Comparator: B Commercially available triclosan/copolymer/fluoride toothpaste	Drug: Triclosan; Brush two times daily for 6 weeks; Drug: Fluoride; Brush two times daily for 6 weeks

Outcome Measures

Primary Outcome Measures

1. Control Established Plaque in Adults [6 weeks]

   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. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.

Secondary Outcome Measures

1. Control Gingivitis in Adults [6 weeks]

   Gingivitis Index (GI) is described as 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. GI score = Sum of all scores divided by the number of sites (teeth scored).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Male or female volunteers 18-65 years of age

2. Good general health

3. Must sign informed consent form

4. Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.

5. 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.

6. Dental Selection Criteria: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0

Exclusion Criteria:

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

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

3. Moderate or advanced periodontal disease

4. History of allergy to iodine

5. History of thyroid disease

6. History of diabetes

7. 2 or more decayed untreated dental sites at screening.

8. Other disease of the hard or soft oral tissues.

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

10. Use of medications that are currently affect salivary flow.

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

12. Pregnant or nursing women.

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

14. Use of tobacco products

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

16. Current use of Antibiotics for any purpose.

17. Presence of an orthodontic appliance.

18. History of allergy to common dentifrice ingredients

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

20. Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms).

21. Smoker

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Louisville, School of Dentistry	Louisville	Kentucky	United States	40292

Sponsors and Collaborators

• Colgate Palmolive

Investigators

• Principal Investigator: Denis Kinane, BDS,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00762515
• Other Study ID Numbers: CRO-2007-GIN-03-RR
• First Posted: Sep 30, 2008
• Last Update Posted: Dec 28, 2010
• Last Verified: Dec 1, 2010

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

Study Results

Participant Flow

Recruitment Details	subjects recruited by the PI at the clinical site.
Pre-assignment Detail	Screening for subjects that met the overall oral health criteria. Followed by a 1 week washout prior to starting any study treatments or procedures.

Arm/Group Title	A -Placebo Comparator	B- Active Comparator
Arm/Group Description	Fluoride toothpaste	Fluoride/triclosan toothpaste (Total)
Period Title: Overall Study
STARTED	22	22
COMPLETED	22	22
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	A -Placebo Comparator	B- Active Comparator	Total
Arm/Group Description	Fluoride toothpaste	Fluoride/triclosan toothpaste (Total)	Total of all reporting groups
Overall Participants	22	22	44
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	22 100%	22 100%	44 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	15 68.2%	13 59.1%	28 63.6%
Male	7 31.8%	9 40.9%	16 36.4%
Region of Enrollment (participants) [Number]
United States	22 100%	22 100%	44 100%

Outcome Measures

1. Primary Outcome

Title	Control Established Plaque in Adults
Description	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. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A -Placebo Comparator	B- Active Comparator
Arm/Group Description	Fluoride toothpaste	Fluoride/triclosan toothpaste (Total)
Measure Participants	22	22
Mean (Standard Deviation) [Units on a scale]	2.42 (0.47)	2.45 (0.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A -Placebo Comparator, B- Active 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	ANCOVA
	Comments	baseline is used a factor

2. Secondary Outcome

Title	Control Gingivitis in Adults
Description	Gingivitis Index (GI) is described as 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. GI score = Sum of all scores divided by the number of sites (teeth scored).
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A -Placebo Comparator	B- Active Comparator
Arm/Group Description	Fluoride toothpaste	Fluoride/triclosan toothpaste (Total)
Measure Participants	22	22
Mean (Standard Deviation) [Units on a scale]	0.54 (0.16)	0.63 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A -Placebo Comparator, B- Active 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	ANCOVA
	Comments	baseline to be used a factor

Adverse Events

Time Frame	7 weeks
Arm/Group Title	A -Placebo Comparator		B- Active Comparator
Arm/Group Description	Fluoride toothpaste		Fluoride/triclosan toothpaste (Total)
All Cause Mortality
	A -Placebo Comparator		B- Active Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	A -Placebo Comparator		B- Active Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	A -Placebo Comparator		B- Active Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (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.