Effectiveness of Toothpaste Tablets on Plaque, Gingival Health and Caries Experiences

Effectiveness of Toothpaste Tablets on Plaque, Gingival Health and Caries Experiences: A 6-week Randomized Controlled Trial

Objectives: To evaluate the effectiveness of toothpaste tablets when compared to conventional dentifrices in removing plaque.

Methods: 50 participants are randomized into two groups: Denttabs toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (P). Both groups utilize their assigned dentifrice for 6 weeks. A pre and post-assessment measures the Gingival Index (GI) and Plaque Index (PI) and Decayed, Missing and Filled Teeth (DMFT). A questionnaire on the use of the product is distributed at the end of the study.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries; Gingival Inflammation
• Intervention / Treatment: Drug: Toothpaste Tablet; Drug: Conventional Toothpaste

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: So Ran Kwon, DDS, MS, PhD; Phone Number: 55118 909 558 5118; Email: sorankwon@llu.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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 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 at each brushing. Brushing is recommended twice daily for two minutes.	Drug: Toothpaste Tablet; Denttabs toothpaste tablets; Other Names: Denttabs Toothpaste Tablets
Active Comparator: Conventional Toothpaste; Subjects are instructed to use the toothpaste at each brushing. Brushing is recommended twice daily for two minutes.	Drug: Conventional Toothpaste; Colgate Cavity Protection toothpaste; Other Names: Colgate Cavity Protection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index Score at Baseline	The quantity of plaque build-up is measured visually using the Quigley-Hein Plaque Index. The Plaque index can range from 0 to 5, with higher numbers indicating more plaque build-up.	Change between baseline at visit 1 and visit 2, six weeks post baseline
Gingival Index Score at Baseline	The severity of gingival inflammation is measured visually using the Loe-Silness Gingival Index. Gingival index can range from 0 to 3, with higher numbers indicating more gingival inflammation.	Change between baseline at visit 1 and visit 2, six weeks post baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DMFT Score at Baseline	Caries experiences is measured visually using the DMFT index. DMFT score can range from 0 to 28, with higher numbers indicating higher caries experiences.	Change between baseline at visit 1 and visit 2, six weeks post baseline
Subject Perception of Product Use	The perception on the product usage is measured using a survey containing questions on feel, texture, flavor, ease of use, eco-friendliness, cost and overall satisfaction. Response is on a 4 point Likert scale ranging from strongly agree (1) to strongly disagree (4).	Visit 2 six 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 (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 8, 2025
• First Submitted That Met QC Criteria: August 8, 2025
• First Posted (Actual): August 15, 2025

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Dentifrice; Gingival Index; Plaque Index; Toothpaste Tablets; Consumer Satisfaction; Caries Experiences
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Infections; Gingival Diseases; Tooth Demineralization; Behavior; Dental Caries; Gingivitis; Consumer Behavior; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Dentifrices; Toothpastes
• Other Study ID Numbers: 5250357

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