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

NCT05805865 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 5220342
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Inflammation

Keywords

Gingival Index; Plaque Index; Dentifrice; Toothpaste Tablets; Consumer Satisfaction

Outcome Measures

Primary Outcomes (2)

• Plaque Index Score at Baseline

  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. 1. Separate flecks of plaque at the cervical margin. 2. A thin, continuous band of plaque (up to 1 mm) at the cer- vical margin. 3. A band of plaque wider than 1 mm but covering less than 1/3 of the side of the crown of the tooth. 4. Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth. 5. 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.

  Change between baseline at visit 1 and visit 2, two weeks post baseline.

• Gingival Index Score at Baseline

  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. 1. = Mild inflammation-slight change in color and little change in texture. 2. = Moderate inflammation-moderate glazing, redness, edema, and hypertrophy. 3. = 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.

  Change between baseline at visit 1 and visit 2, two weeks post baseline.

Secondary Outcomes (1)

• Subject Perception of Product Use

  Visit 2 two weeks post study enrollment

Study Arms (2)

Toothpaste Tablet

EXPERIMENTAL

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

Drug: Toothpaste Tablet

Conventional Toothpaste

ACTIVE COMPARATOR

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

Drug: Conventional Toothpaste

Interventions

Toothpaste Tablet DRUG

Colgate Anywhere Toothpaste Tablets

Toothpaste Tablet

Conventional Toothpaste DRUG

Colgate Cavity Protection

Conventional Toothpaste

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects who are pregnant and/or nursing;
• Subjects under the age of 18.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Gingivitis; Consumer Behavior

Interventions

Toothpastes

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Professor, Director of Student Research
• Organization: Loma Linda University Health

sorankwon@llu.edu

909 558 5118

Study Officials

• So Ran Kwon, DDS, MS, PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator blinded to group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: January 3, 2023
• Primary Completion: January 23, 2023
• Study Completion: January 23, 2023
• Last Updated: February 21, 2025
• Results First Posted: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)