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

Not Applicable

Not yet recruiting

• Conditions: Gingival Inflammation; Dental Caries
• Interventions: Drug: Toothpaste Tablet; Drug: Conventional Toothpaste

• Registration Number: NCT07124533
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-08
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Study Start: 2025-09-01
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toothpaste Tablet	Toothpaste Tablet	Subjects are instructed to use one toothpaste tablet at each brushing. Brushing is recommended twice daily for two minutes.
Conventional Toothpaste	Conventional Toothpaste	Subjects are instructed to use the toothpaste at each brushing. Brushing is recommended twice daily for two minutes.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (2)

Loma Linda University Health; 🇺🇸 Loma Linda, California, United States

Loma Linda University; 🇺🇸 Loma Linda, California, United States