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

Gingival Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05805865
• Other study ID #: 5220342
• Status: Completed
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: January 23, 2023

Study information

• Verified date: March 2023
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 23, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Inflammation
• Gingivitis
• Inflammation

Intervention

Device:
• Toothpaste Tablet
Colgate Anywhere Toothpaste Tablets
• Conventional Toothpaste
Colgate Cavity Protection

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change between baseline at visit 1 and visit 2, two weeks post baseline.
Primary	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.	Change between baseline at visit 1 and visit 2, two weeks post baseline.
Secondary	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.	Visit 2 two weeks post study enrollment