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

Primary Purpose

Gingival Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Toothpaste Tablet
Conventional Toothpaste
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingival Inflammation focused on measuring Gingival Index, Plaque Index, Dentifrice, Toothpaste Tablets, Consumer Satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: Subjects who are pregnant and/or nursing; Subjects under the age of 18.

Sites / Locations

  • Loma Linda University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Toothpaste Tablet

Conventional Toothpaste

Arm Description

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

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

Outcomes

Primary Outcome Measures

Plaque Index Score
Plaque was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Each tooth was divided into six surfaces, three facial and three lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Teeth included in the scoring were: #3, 7, 12, 19, 23, 28. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0: No plaque. Separate flecks of plaque at the cervical margin. A thin, continuous band of plaque (up to 1 mm) at the cer- vical margin. A band of plaque wider than 1 mm but covering less than 1/3 of the side of the crown of the tooth. Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth. Plaque covering 2/3 or more of the side of the crown of the tooth. Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth.
Gingival Index Score
Gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was divided into six surfaces, three facial and three lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Teeth included in the scoring were: #3, 7, 12, 19, 23, 28. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation. = Mild inflammation-slight change in color and little change in texture. = Moderate inflammation-moderate glazing, redness, edema, and hypertrophy. = Severe inflammation-marked redness and hypertrophy. Tendency for spontaneous bleeding. Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth.

Secondary Outcome Measures

Subject Perception of Product Use
This is a composite measurement based on questionnaire response. Subject swill answer 7 questions related to cleanliness, flavor, ease of use, eco-friendliness, willingness to switch, satisfaction, texture.

Full Information

First Posted
March 28, 2023
Last Updated
March 28, 2023
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT05805865
Brief Title
Efficacy of Eco-Friendly Toothpaste Tablets Versus Conventional Toothpaste Using PI and GI Index
Official Title
Efficacy of Eco-Friendly Toothpaste Tablets Versus Conventional Toothpaste Using PI and GI Index
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
January 23, 2023 (Actual)
Study Completion Date
January 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Inflammation
Keywords
Gingival Index, Plaque Index, Dentifrice, Toothpaste Tablets, Consumer Satisfaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Investigator blinded to group
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toothpaste Tablet
Arm Type
Experimental
Arm Description
Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes.
Arm Title
Conventional Toothpaste
Arm Type
Active Comparator
Arm Description
Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes.
Intervention Type
Device
Intervention Name(s)
Toothpaste Tablet
Intervention Description
Colgate Anywhere Toothpaste Tablets
Intervention Type
Device
Intervention Name(s)
Conventional Toothpaste
Intervention Description
Colgate Cavity Protection
Primary Outcome Measure Information:
Title
Plaque Index Score
Description
Plaque was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Each tooth was divided into six surfaces, three facial and three lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Teeth included in the scoring were: #3, 7, 12, 19, 23, 28. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0: No plaque. Separate flecks of plaque at the cervical margin. A thin, continuous band of plaque (up to 1 mm) at the cer- vical margin. A band of plaque wider than 1 mm but covering less than 1/3 of the side of the crown of the tooth. Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth. Plaque covering 2/3 or more of the side of the crown of the tooth. Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth.
Time Frame
Change between baseline at visit 1 and visit 2, two weeks post baseline.
Title
Gingival Index Score
Description
Gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was divided into six surfaces, three facial and three lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Teeth included in the scoring were: #3, 7, 12, 19, 23, 28. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation. = Mild inflammation-slight change in color and little change in texture. = Moderate inflammation-moderate glazing, redness, edema, and hypertrophy. = Severe inflammation-marked redness and hypertrophy. Tendency for spontaneous bleeding. Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth.
Time Frame
Change between baseline at visit 1 and visit 2, two weeks post baseline.
Secondary Outcome Measure Information:
Title
Subject Perception of Product Use
Description
This is a composite measurement based on questionnaire response. Subject swill answer 7 questions related to cleanliness, flavor, ease of use, eco-friendliness, willingness to switch, satisfaction, texture.
Time Frame
Visit 2 two weeks post study enrollment

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Subjects who are pregnant and/or nursing; Subjects under the age of 18.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
So Ran Kwon, DDS, MS, PhD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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