Efficacy of Eco-Friendly Toothpaste Tablets Versus Conventional Toothpaste Using PI and GI Index

NCT ID: NCT05805865

Last Updated: 2025-02-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2023-01-23

Brief Summary

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Objectives: To assess the change in gingival index (GI) and plaque index (PI) when comparing the use of toothpaste tablets to conventional toothpaste.

Methods: 40 participants were randomized into two groups: Colgate's toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (C). Both groups utilized their assigned dentifrice for 2 weeks. A pre and post-assessment measured the GI and PI index. A questionnaire on the use of the product was distributed.

Detailed Description

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Conditions

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Gingival Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
Investigator blinded to group

Study Groups

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Toothpaste Tablet

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

Group Type EXPERIMENTAL

Toothpaste Tablet

Intervention Type DRUG

Colgate Anywhere Toothpaste Tablets

Conventional Toothpaste

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

Group Type ACTIVE_COMPARATOR

Conventional Toothpaste

Intervention Type DRUG

Colgate Cavity Protection

Interventions

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Toothpaste Tablet

Colgate Anywhere Toothpaste Tablets

Intervention Type DRUG

Conventional Toothpaste

Colgate Cavity Protection

Intervention Type DRUG

Eligibility Criteria

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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 who are pregnant and/or nursing;
2. Subjects under the age of 18.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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So Ran Kwon, DDS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

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Loma Linda University

Loma Linda, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5220342

Identifier Type: -

Identifier Source: org_study_id

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