Trial Outcomes & Findings for Efficacy of Eco-Friendly Toothpaste Tablets Versus Conventional Toothpaste Using PI and GI Index (NCT NCT05805865)

Results Overview

Plaque was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Each tooth was divided into six surfaces, three facial and three lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Teeth included in the scoring were: #3, 7, 12, 19, 23, 28. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0: No plaque. 1. Separate flecks of plaque at the cervical margin. 2. A thin, continuous band of plaque (up to 1 mm) at the cer- vical margin. 3. A band of plaque wider than 1 mm but covering less than 1/3 of the side of the crown of the tooth. 4. Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth. 5. Plaque covering 2/3 or more of the side of the crown of the tooth. Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

Change between baseline at visit 1 and visit 2, two weeks post baseline.

Results posted on

2025-02-21

Participant Flow

Participant milestones

Participant milestones
Measure	Toothpaste Tablet Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes. Toothpaste Tablet: Colgate Anywhere Toothpaste Tablets	Conventional Toothpaste Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes. Conventional Toothpaste: Colgate Cavity Protection
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Toothpaste Tablet n=20 Participants Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes. Toothpaste Tablet: Colgate Anywhere Toothpaste Tablets	Conventional Toothpaste n=20 Participants Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes. Conventional Toothpaste: Colgate Cavity Protection	Total n=40 Participants Total of all reporting groups
Age, Continuous	24.95 years STANDARD_DEVIATION 4.20 • n=20 Participants	25.35 years STANDARD_DEVIATION 4.15 • n=20 Participants	25.15 years STANDARD_DEVIATION 4.12 • n=40 Participants
Sex: Female, Male Female	14 Participants n=20 Participants	12 Participants n=20 Participants	26 Participants n=40 Participants
Sex: Female, Male Male	6 Participants n=20 Participants	8 Participants n=20 Participants	14 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	20 participants n=20 Participants	20 participants n=20 Participants	40 participants n=40 Participants

PRIMARY outcome

Timeframe: Change between baseline at visit 1 and visit 2, two weeks post baseline.

Plaque was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Each tooth was divided into six surfaces, three facial and three lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Teeth included in the scoring were: #3, 7, 12, 19, 23, 28. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0: No plaque. 1. Separate flecks of plaque at the cervical margin. 2. A thin, continuous band of plaque (up to 1 mm) at the cer- vical margin. 3. A band of plaque wider than 1 mm but covering less than 1/3 of the side of the crown of the tooth. 4. Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth. 5. Plaque covering 2/3 or more of the side of the crown of the tooth. Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth.

Outcome measures

Outcome measures
Measure	Toothpaste Tablet n=20 Participants Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes. Toothpaste Tablet: Colgate Anywhere Toothpaste Tablets	Conventional Toothpaste n=20 Participants Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes. Conventional Toothpaste: Colgate Cavity Protection
Plaque Index Score at Baseline	2.80 Score on a scale Standard Deviation 0.58	2.78 Score on a scale Standard Deviation 0.46

PRIMARY outcome

Timeframe: Change between baseline at visit 1 and visit 2, two weeks post baseline.

Gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was divided into six surfaces, three facial and three lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Teeth included in the scoring were: #3, 7, 12, 19, 23, 28. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation. 1. = Mild inflammation-slight change in color and little change in texture. 2. = Moderate inflammation-moderate glazing, redness, edema, and hypertrophy. 3. = Severe inflammation-marked redness and hypertrophy. Tendency for spontaneous bleeding. Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth.

Outcome measures

Outcome measures
Measure	Toothpaste Tablet n=20 Participants Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes. Toothpaste Tablet: Colgate Anywhere Toothpaste Tablets	Conventional Toothpaste n=20 Participants Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes. Conventional Toothpaste: Colgate Cavity Protection
Gingival Index Score at Baseline	1.35 Score on a scale Standard Deviation 0.26	1.37 Score on a scale Standard Deviation 0.24

SECONDARY outcome

Timeframe: Visit 2 two weeks post study enrollment

This is a composite measurement based on questionnaire response. Subjects will answer 7 questions related to cleanliness, flavor, ease of use, eco-friendliness, willingness to switch, satisfaction, texture. This is measured on a Likert Scale from 1-4. 1 represents strongly agree with overall product satisfaction. 4 represents strongly disagree with overall product satisfaction.

Outcome measures

Outcome measures
Measure	Toothpaste Tablet n=20 Participants Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes. Toothpaste Tablet: Colgate Anywhere Toothpaste Tablets	Conventional Toothpaste n=20 Participants Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes. Conventional Toothpaste: Colgate Cavity Protection
Subject Perception of Product Use	2.0 units on a scale Standard Deviation 0.4	1.7 units on a scale Standard Deviation 0.4

Adverse Events

Toothpaste Tablet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Toothpaste

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

Professor, Director of Student Research

Loma Linda University Health

Phone: 909 558 5118

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place