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

NCT07124533 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 5250357
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dental Caries; Gingival Inflammation

Keywords

Gingival Index; Plaque Index; Dentifrice; Toothpaste Tablets; Caries Experiences; Consumer Satisfaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• DMFT Score at Baseline

  Change between baseline at visit 1 and visit 2, six weeks post baseline

• Subject Perception of Product Use

  Visit 2 six weeks post study enrollment

Study Arms (2)

Toothpaste Tablet

EXPERIMENTAL

Subjects are instructed to use one toothpaste tablet at each brushing. Brushing is recommended twice daily for two minutes.

Drug: Toothpaste Tablet

Conventional Toothpaste

ACTIVE COMPARATOR

Subjects are instructed to use the toothpaste at each brushing. Brushing is recommended twice daily for two minutes.

Drug: Conventional Toothpaste

Interventions

Toothpaste Tablet DRUG

Denttabs toothpaste tablets

Also known as: Denttabs Toothpaste Tablets

Toothpaste Tablet

Conventional Toothpaste DRUG

Colgate Cavity Protection toothpaste

Also known as: Colgate Cavity Protection

Conventional Toothpaste

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Subjects under the age of 18.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (2)

Loma Linda University Health

Loma Linda, California, 92350, United States

Location

Loma Linda University

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Gingivitis; Dental Caries; Consumer Behavior

Interventions

Toothpastes

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Behavior

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• So Ran Kwon, DDS, MS, PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

So Ran Kwon, DDS, MS, PhD

CONTACT

909 558 5118; sorankwon@llu.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 15, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)