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

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Toothpaste Experimental Toothpaste Active Comparator
Hide 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
Arm/Group Title Control Toothpaste Experimental Toothpaste Active Comparator Total
Hide 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
Hide 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
1.Primary Outcome
Title Gingivitis Scores
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Toothpaste Experimental Toothpaste Active Comparator
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Toothpaste Experimental Toothpaste Active Comparator
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Toothpaste Experimental Toothpaste Active Comparator
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Toothpaste Experimental Toothpaste Active Comparator
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Toothpaste Experimental Toothpaste Active Comparator
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Toothpaste Experimental Toothpaste Active Comparator
Hide 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)
Show Statistical Analysis 1 Hide 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]
Time Frame Baseline, 3 and 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Toothpaste Experimental Toothpaste Active Comparator
Hide 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   --/--   --/--   --/-- 
Show Serious Adverse Events Hide 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%) 
Show Other (Not Including Serious) Adverse Events Hide 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%) 
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
Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT02243046     History of Changes
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