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

NCT07124533 — Phase 3, Not yet recruiting, 50 participants, Loma Linda University

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

Registry	NCT07124533
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	50 (Estimated)
Sponsor	Loma Linda University (Other)
Conditions	Gingival Inflammation, Dental Caries
Interventions	Toothpaste Tablet, Conventional Toothpaste (Drug)
Dates	start 2026-12-01 (estimated), primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2025-08-15, last updated 2026-07-10
Locations	2 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Toothpaste Tablet	Experimental	Drug: Toothpaste Tablet	Subjects are instructed to use one toothpaste tablet at each brushing. Brushing is recommended twice daily for two minutes.
Conventional Toothpaste	Active comparator	Drug: Conventional Toothpaste	Subjects are instructed to use the toothpaste at each brushing. Brushing is recommended twice daily for two minutes.

Toothpaste Tablet (Drug), also known as Denttabs Toothpaste Tablets: Denttabs toothpaste tablets
Conventional Toothpaste (Drug), also known as Colgate Cavity Protection: Colgate Cavity Protection toothpaste

+Outcome measures

Primary outcomes

Plaque Index Score at Baseline [Change between baseline at visit 1 and visit 2, six weeks post 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.
Gingival Index Score at Baseline [Change between baseline at visit 1 and visit 2, six weeks post 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.

Secondary outcomes

DMFT Score at Baseline [Change between baseline at visit 1 and visit 2, six weeks post 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.
Subject Perception of Product Use [Visit 2 six weeks post study enrollment]: 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).

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (2)

Facility	City	Country	Status
Loma Linda University Health	Loma Linda, California	United States
Loma Linda University	Loma Linda, California	United States

+Investigators

So Ran Kwon, DDS, MS, PhD, Principal investigator, Loma Linda University