Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria

• Sponsor: Colgate Palmolive (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02194621
• Collaborator: (none)
• Enrollment: 128
• Location: 1
• Arms: 3
• Duration (Months): 1.9
• Patients Per Site Per Month: 66

Study Details

Study Description

Brief Summary

The primary objective was to evaluate the antibacterial effects of two toothpastes containing 0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as compared to a control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours after 13 days of product use. A secondary objective was to demonstrate that a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234% sodium fluoride and a flavor with odor-masking ingredients in silica base (Colgate Total Toothpaste-Flavor Option 1) provides a level of antibacterial efficacy that is "equivalent" to a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234% sodium fluoride and a regular flavor in silica base (Colgate Total Toothpaste-Flavor Option 2) after 13 days of product use.

Condition or Disease	Intervention/Treatment	Phase
Oral Bacteria Levels in the Mouth	Drug: Total Flavor option 1; Drug: Total Flavor option 2; Drug: Placebo toothpaste: Crest Cavity Protection toothpaste	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Randomized, Single Center, Three Cell, Double Blind and Parallel Groups Clinical Study Conducted in Newark, NJ to Evaluate the Antibacterial Effects of Two Toothpastes Containing 0.3% Triclosan/2% Copolymer/0.243% Sodium Fluoride in a Silica Base as Compared to a Control Regular Fluoride Toothpaste on Oral Bacteria 12 Hours After 13 Days Product Use.
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Total Flavor Option 1 Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 1 ingredient - Total Flavor Option 1	Drug: Total Flavor option 1; Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1; Other Names: Total toothpaste
Experimental: Total Flavor Option 2 Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 2 ingredient. Total Flavor Option 2	Drug: Total Flavor option 2; Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2; Other Names: Total toothpaste
Placebo Comparator: Crest Toothpaste Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)	Drug: Placebo toothpaste: Crest Cavity Protection toothpaste; Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed); Other Names: Crest Anti-Cavity toothpaste

Outcome Measures

Primary Outcome Measures

1. Anaerobic Bacteria [Baseline]

   Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.

2. Anaerobic Bacteria [12 hours]

   Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.

3. Malodor Bacteria (Breath Odor Causing Bacteria) [Baseline]

   Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.

4. Malodor Bacteria (Breath Odor Causing Bacteria) [12 hours]

   Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 58 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Males and females in good general health aged 18 to 70 years.

2. A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and sampling schedules.

3. A minimum of 20 natural teeth with facial and lingual scorable surfaces.

4. Adequate oral hygiene and no signs of oral neglect.

5. Good periodontal health. Enrolled subjects will have no more than five periodontal pockets of 5 mm.

6. Subjects with gingival index greater than or equal to 1.0 (Loe-Silness Index) and plaque index greater than or equal to 1.5 (Turesky modification of Quigley-Hein Index) will be enrolled.

Exclusion Criteria:

1. History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients.

2. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars

3. History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.

4. History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.

5. Subjects on antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.

6. Significant oral soft tissue pathology, systemically related gingival enlargement, severe gingivitis (based on a visual examinations).

7. History of active severe periodontal disease with bleeding gums and loose teeth.

8. Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).will not be included in the tooth count.

9. Fixed or removable orthodontic appliance or removable partial dentures.

10. Participation in a dental plaque/gingivitis clinical study involving oral care products, within the last 30 days. History of dental prophylaxis or treatments in the past month.

11. Self reported pregnancy or lactation.

12. History or current use of objects to pierce the lips or tongue.

13. Subjects known to be an alcoholic, or a recovering alcoholic.

14. History or current use of recreational drugs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rutgers School of Dental Medicine	Newark	New Jersey	United States	07107

Sponsors and Collaborators

• Colgate Palmolive

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Colgate Palmolive
• ClinicalTrials.gov Identifier: NCT02194621
• Other Study ID Numbers: CRO-1113-BACT-PS-NJ
• First Posted: Jul 18, 2014
• Last Update Posted: Apr 15, 2016
• Last Verified: Jul 1, 2014

Study Results

Participant Flow

Recruitment Details	subject recruitment is completed locally at the clinical site
Pre-assignment Detail	There will be a one (1) week wash out phase with commercially available fluoride toothpaste prior to any study intervention being assigned.

Arm/Group Title	Total Flavor Option 1	Total Flavor Option 2	Crest Toothpaste
Arm/Group Description	Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1 Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1	Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2 Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2	Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed) Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)
Period Title: Overall Study
STARTED	43	42	43
COMPLETED	37	36	34
NOT COMPLETED	6	6	9

Baseline Characteristics

Arm/Group Title	Total Flavor Option 1	Total Flavor Option 2	Crest Toothpaste	Total
Arm/Group Description	Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1 Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1	Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2 Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2	Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed) Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)	Total of all reporting groups
Overall Participants	43	42	43	128
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.6 (10.2)	34.2 (10.34)	35.9 (12.08)	35.4 (10.82)
Sex: Female, Male (Count of Participants)
Female	28 65.1%	29 69%	24 55.8%	81 63.3%
Male	15 34.9%	13 31%	19 44.2%	47 36.7%
Region of Enrollment (participants) [Number]
United States	43 100%	42 100%	43 100%	128 100%

Outcome Measures

1. Primary Outcome

Title	Anaerobic Bacteria
Description	Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total Flavor Option 1	Total Flavor Option 2	Crest Toothpaste
Arm/Group Description	Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1 Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1	Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2 Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2	Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed) Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)
Measure Participants	43	42	43
Mean (Standard Deviation) [colony forming units]	8.40 (0.33)	8.42 (0.25)	8.43 (0.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Total Flavor Option 1, Total Flavor Option 2, Crest 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	ANOVA
	Comments

2. Primary Outcome

Title	Anaerobic Bacteria
Description	Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.
Time Frame	12 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total Flavor Option 1	Total Flavor Option 2	Crest Toothpaste
Arm/Group Description	Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1 Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1	Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2 Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2	Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed) Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)
Measure Participants	37	36	34
Mean (Standard Error) [colony forming units]	7.68 (0.09)	7.71 (0.09)	8.37 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Total Flavor Option 2, Crest 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	<0.001
	Comments
	Method	ANCOVA
	Comments

3. Primary Outcome

Title	Malodor Bacteria (Breath Odor Causing Bacteria)
Description	Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total Flavor Option 1	Total Flavor Option 2	Crest Toothpaste
Arm/Group Description	Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1 Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1	Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2 Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2	Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed) Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)
Measure Participants	37	36	34
Mean (Standard Deviation) [colony forming units]	6.26 (0.44)	6.26 (0.50)	6.40 (0.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Total Flavor Option 1, Total Flavor Option 2, Crest 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	ANOVA
	Comments

4. Primary Outcome

Title	Malodor Bacteria (Breath Odor Causing Bacteria)
Description	Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.
Time Frame	12 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total Flavor Option 1	Total Flavor Option 2	Crest Toothpaste
Arm/Group Description	Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1 Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1	Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2 Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2	Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed) Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)
Measure Participants	37	36	34
Mean (Standard Error) [colony forming units]	5.99 (0.07)	5.92 (0.07)	6.32 (0.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Total Flavor Option 1, Total Flavor Option 2, Crest 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	0.002
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Time Frame	Baseline, 12 hours and 2 weeks
Arm/Group Title	Total Flavor Option 1		Total Flavor Option 2		Crest Toothpaste
Arm/Group Description	Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1 Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1		Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2 Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2		Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed) Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)
All Cause Mortality
	Total Flavor Option 1		Total Flavor Option 2		Crest Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Total Flavor Option 1		Total Flavor Option 2		Crest Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/42 (0%)		0/43 (0%)
Other (Not Including Serious) Adverse Events
	Total Flavor Option 1		Total Flavor Option 2		Crest Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/42 (0%)		0/43 (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 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.