Trial Outcomes & Findings for The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis (NCT NCT02243046)

NCT ID: NCT02243046

Last Updated: 2019-02-25

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 162 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2019-02-25

Participant Flow

Participant milestones

Measure	Control Toothpaste 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.	Experimental Toothpaste 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.	Active Comparator 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 Study STARTED	55	54	53
Overall Study 3 Month	54	53	51
Overall Study 6 Month	54	53	49
Overall Study COMPLETED	54	53	49
Overall Study NOT COMPLETED	1	1	4

Reasons for withdrawal

Measure	Control Toothpaste 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.	Experimental Toothpaste 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.	Active Comparator 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 Study Lost to Follow-up	1	1	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Control Toothpaste n=55 Participants 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.	Experimental Toothpaste n=54 Participants 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.	Active Comparator n=53 Participants 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 n=162 Participants Total of all reporting groups
Age, Continuous	30.52 years STANDARD_DEVIATION 10.99 • n=5 Participants	30.92 years STANDARD_DEVIATION 9.82 • n=7 Participants	30.39 years STANDARD_DEVIATION 13.47 • n=5 Participants	30.62 years STANDARD_DEVIATION 11.39 • n=4 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	31 Participants n=7 Participants	28 Participants n=5 Participants	93 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	23 Participants n=7 Participants	25 Participants n=5 Participants	69 Participants n=4 Participants
Region of Enrollment Dominican Republic	55 participants n=5 Participants	54 participants n=7 Participants	53 participants n=5 Participants	162 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline

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)

Outcome measures

Measure	Control Toothpaste n=55 Participants 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.	Experimental Toothpaste n=54 Participants 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.	Active Comparator n=53 Participants 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.
Gingivitis Scores	1.48 units on a scale Standard Deviation 0.23	1.57 units on a scale Standard Deviation 0.28	1.49 units on a scale Standard Deviation 0.20

PRIMARY outcome

Timeframe: 3 months (from Baseline)

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)

Outcome measures

Measure	Control Toothpaste n=54 Participants 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.	Experimental Toothpaste n=53 Participants 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.	Active Comparator n=51 Participants 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.
Gingivitis Scores	1.46 units on a scale Standard Deviation 0.19	1.33 units on a scale Standard Deviation 0.23	1.25 units on a scale Standard Deviation 0.18

PRIMARY outcome

Timeframe: 6 months (from Baseline)

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)

Outcome measures

Measure	Control Toothpaste n=54 Participants 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.	Experimental Toothpaste n=53 Participants 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.	Active Comparator n=49 Participants 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.
Gingivitis Scores	1.44 units on a scale Standard Deviation 0.20	1.23 units on a scale Standard Deviation 0.23	1.19 units on a scale Standard Deviation 0.17

PRIMARY outcome

Timeframe: Baseline

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)

Outcome measures

Measure	Control Toothpaste n=55 Participants 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.	Experimental Toothpaste n=54 Participants 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.	Active Comparator n=53 Participants 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.
Dental Plaque Scores	2.91 units on a scale Standard Deviation 0.24	2.95 units on a scale Standard Deviation 0.29	2.90 units on a scale Standard Deviation 0.20

PRIMARY outcome

Timeframe: 3 months (from Baseline)

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)

Outcome measures

Measure	Control Toothpaste n=54 Participants 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.	Experimental Toothpaste n=53 Participants 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.	Active Comparator n=51 Participants 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.
Dental Plaque Scores	2.59 units on a scale Standard Deviation 0.29	2.16 units on a scale Standard Deviation 0.53	2.10 units on a scale Standard Deviation 0.36

PRIMARY outcome

Timeframe: 6 months (from Baseline)

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)

Outcome measures

Measure	Control Toothpaste n=54 Participants 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.	Experimental Toothpaste n=53 Participants 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.	Active Comparator n=49 Participants 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.
Dental Plaque Scores	2.47 units on a scale Standard Deviation 0.42	1.82 units on a scale Standard Deviation 0.45	1.75 units on a scale Standard Deviation 0.39

Adverse Events

Control Toothpaste

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental Toothpaste

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Franklin Garcia-Godoy

Global Research Consultants

Phone: 954-888-9102

Email: fgarciagodoy@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60