The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis

• ClinicalTrials.gov Identifier: NCT02243046
• Recruitment Status: Completed
• First Posted: September 17, 2014
• Results First Posted: May 4, 2016
• Last Update Posted: February 25, 2019
• Sponsor: Colgate Palmolive
• Information provided by (Responsible Party): Colgate Palmolive

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Dental Plaque and Gingivitis
• Interventions: Drug: Control toothpaste; Drug: Experimental toothpaste; Drug: Active Comparator
• Enrollment: 162

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Control Toothpaste	Experimental Toothpaste	Active Comparator
Arm/Group Description	1450 ppm Fluoride toothpaste Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride toothpaste with a zinc base Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
Period Title: Overall Study
Started	55	54	53
3 Month	54 [1]	53 [1]	51 [2]
6 Month	54	53	49 [3]
Completed	54	53	49
Not Completed	1	1	4
Reason Not Completed
Lost to Follow-up	1	1	4
[1] 1 subject didn't return for 3 month clinic visit; [2] 2 subjects didn't return for 3 month clinic visit; [3] 2 subjects didn't return for 6 month clinic visit

Baseline Characteristics

Arm/Group Title		Control Toothpaste	Experimental Toothpaste	Active Comparator	Total
Arm/Group Description		1450 ppm Fluoride toothpaste Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride toothpaste with a zinc base Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	Total of all reporting groups
Overall Number of Baseline Participants		55	54	53	162
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	55 participants	54 participants	53 participants	162 participants
		30.52 (10.99)	30.92 (9.82)	30.39 (13.47)	30.62 (11.39)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	55 participants	54 participants	53 participants	162 participants
	Female	34 61.8%	31 57.4%	28 52.8%	93 57.4%
	Male	21 38.2%	23 42.6%	25 47.2%	69 42.6%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Dominican Republic	Number Analyzed	55 participants	54 participants	53 participants	162 participants
		55	54	53	162

Outcome Measures

1. Primary Outcome

Title	Gingivitis Scores
Description	Gingivitis scale (Loe & Silness Gingival Index) 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)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Toothpaste	Experimental Toothpaste	Active Comparator
Arm/Group Description:	1450 ppm Fluoride toothpaste Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride toothpaste with a zinc base Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
Overall Number of Participants Analyzed	55	54	53
Mean (Standard Deviation); Unit of Measure: units on a scale
	1.48 (0.23)	1.57 (0.28)	1.49 (0.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Toothpaste, Experimental Toothpaste, Active Comparator
	Comments	The null hypothesis states that there is no difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.091
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]

2. Primary Outcome

Title	Gingivitis Scores
Description	Gingivitis scale (Loe & Silness Gingival Index) 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)
Time Frame	3 months (from Baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Toothpaste	Experimental Toothpaste	Active Comparator
Arm/Group Description:	1450 ppm Fluoride toothpaste Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride toothpaste with a zinc base Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
Overall Number of Participants Analyzed	54	53	51
Mean (Standard Deviation); Unit of Measure: units on a scale
	1.46 (0.19)	1.33 (0.23)	1.25 (0.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Toothpaste, Experimental Toothpaste, Active Comparator
	Comments	The null hypothesis states that there is no difference between groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

3. Primary Outcome

Title	Gingivitis Scores
Description	Gingivitis scale (Loe & Silness Gingival Index) 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)
Time Frame	6 months (from Baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Toothpaste	Experimental Toothpaste	Active Comparator
Arm/Group Description:	1450 ppm Fluoride toothpaste Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride toothpaste with a zinc base Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
Overall Number of Participants Analyzed	54	53	49
Mean (Standard Deviation); Unit of Measure: units on a scale
	1.44 (0.20)	1.23 (0.23)	1.19 (0.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Toothpaste, Experimental Toothpaste, Active Comparator
	Comments	The null hypothesis states that there is no difference between groups
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

4. Primary Outcome

Title	Dental Plaque Scores
Description	Dental Plaque (Quigley-Hein, Turesky Modification Index) 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	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Toothpaste	Experimental Toothpaste	Active Comparator
Arm/Group Description:	1450 ppm Fluoride toothpaste Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride toothpaste with a zinc base Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
Overall Number of Participants Analyzed	55	54	53
Mean (Standard Deviation); Unit of Measure: units on a scale
	2.91 (0.24)	2.95 (0.29)	2.90 (0.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Toothpaste, Experimental Toothpaste, Active Comparator
	Comments	The null hypothesis states that there is no difference between groups
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.571
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]

5. Primary Outcome

Title	Dental Plaque Scores
Description	Dental Plaque (Quigley-Hein, Turesky Modification Index) 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	3 months (from Baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Toothpaste	Experimental Toothpaste	Active Comparator
Arm/Group Description:	1450 ppm Fluoride toothpaste Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride toothpaste with a zinc base Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
Overall Number of Participants Analyzed	54	53	51
Mean (Standard Deviation); Unit of Measure: units on a scale
	2.59 (0.29)	2.16 (0.53)	2.10 (0.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Toothpaste, Experimental Toothpaste, Active Comparator
	Comments	The null hypothesis states that there is no difference between groups
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

6. Primary Outcome

Title	Dental Plaque Scores
Description	Dental Plaque (Quigley-Hein, Turesky Modification Index) 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	6 months (from Baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Toothpaste	Experimental Toothpaste	Active Comparator
Arm/Group Description:	1450 ppm Fluoride toothpaste Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride toothpaste with a zinc base Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
Overall Number of Participants Analyzed	54	53	49
Mean (Standard Deviation); Unit of Measure: units on a scale
	2.47 (0.42)	1.82 (0.45)	1.75 (0.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Toothpaste, Experimental Toothpaste, Active Comparator
	Comments	The null hypothesis states that there is no difference between groups
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Adverse Events

Time Frame	Baseline, 3 and 6 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Control Toothpaste	Experimental Toothpaste	Active Comparator
Arm/Group Description	1450 ppm Fluoride toothpaste Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride toothpaste with a zinc base Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
All-Cause Mortality
	Control Toothpaste	Experimental Toothpaste	Active Comparator
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	Control Toothpaste	Experimental Toothpaste	Active Comparator
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/55 (0.00%)	0/54 (0.00%)	0/53 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Control Toothpaste	Experimental Toothpaste	Active Comparator
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/55 (0.00%)	0/54 (0.00%)	0/53 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Franklin Garcia-Godoy
• Organization: Global Research Consultants
• Phone: 954-888-9102
• EMail: fgarciagodoy@gmail.com

• Responsible Party: Colgate Palmolive
• ClinicalTrials.gov Identifier: NCT02243046
• Other Study ID Numbers: CRO-2014-11-PG-ZNPTCN-ED
• First Submitted: September 16, 2014
• First Posted: September 17, 2014
• Results First Submitted: January 28, 2016
• Results First Posted: May 4, 2016
• Last Update Posted: February 25, 2019