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

Phase 3Not Yet RecruitingNCT07124533

Loma Linda University50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Gingival Inflammation Dental Caries

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Loma Linda University Health

Loma Linda, California, United States

Loma Linda University

Loma Linda, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

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

Secondary Outcomes

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.

Time frame: 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).

Time frame: Visit 2 six weeks post study enrollment

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts