Efficacy of Eco-Friendly Toothpaste Tablets Versus Conventional Toothpaste Using PI and GI Index

Objectives: To assess the change in gingival index (GI) and plaque index (PI) when comparing the use of toothpaste tablets to conventional toothpaste.

Methods: 40 participants were randomized into two groups: Colgate's toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (C). Both groups utilized their assigned dentifrice for 2 weeks. A pre and post-assessment measured the GI and PI index. A questionnaire on the use of the product was distributed.

Study Overview

• Status: Completed
• Conditions: Gingival Inflammation
• Intervention / Treatment: Drug: Toothpaste Tablet; Drug: Conventional Toothpaste

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subjects are 18 years or older;
2. Subjects who will comply with study protocol;
3. Subjects who can read and understand the consent form;
4. Subjects available during the study period;
5. Subjects have more than 20 teeth.

Exclusion Criteria:

1. Subjects who are pregnant and/or nursing;
2. Subjects under the age of 18.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Toothpaste Tablet; Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes.	Drug: Toothpaste Tablet; Colgate Anywhere Toothpaste Tablets
Active Comparator: Conventional Toothpaste; Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes.	Drug: Conventional Toothpaste; Colgate Cavity Protection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index Score at 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.; Separate flecks of plaque at the cervical margin.; A thin, continuous band of plaque (up to 1 mm) at the cer- vical margin.; A band of plaque wider than 1 mm but covering less than 1/3 of the side of the crown of the tooth.; Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth.; 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.	Change between baseline at visit 1 and visit 2, two weeks post baseline.
Gingival Index Score at 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.; = Mild inflammation-slight change in color and little change in texture.; = Moderate inflammation-moderate glazing, redness, edema, and hypertrophy.; = 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.	Change between baseline at visit 1 and visit 2, two weeks post baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Perception of Product Use	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.	Visit 2 two weeks post study enrollment

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: So Ran Kwon, DDS, MS, PhD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Actual): January 23, 2023
• Study Completion (Actual): January 23, 2023

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Dentifrice; Gingival Index; Plaque Index; Toothpaste Tablets; Consumer Satisfaction
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Infections; Gingival Diseases; Inflammation; Gingivitis
• Other Study ID Numbers: 5220342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes