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

Phase 3

Completed

Conditions: Gingival Inflammation

Interventions: Drug: Toothpaste Tablet
Drug: Conventional Toothpaste

Registration Number: NCT05805865

Lead Sponsor: Loma Linda University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toothpaste Tablet	Toothpaste Tablet	Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes.
Conventional Toothpaste	Conventional Toothpaste	Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes.

Primary Outcome Measures

Name	Time	Method
Plaque Index Score at Baseline	Change between baseline at visit 1 and visit 2, two weeks post 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.
Gingival Index Score at Baseline	Change between baseline at visit 1 and visit 2, two weeks post 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.

Secondary Outcome Measures

Name	Time	Method
Subject Perception of Product Use	Visit 2 two weeks post study enrollment	This is a composite measurement based on questionnaire response. Subjects will answer 7 questions related to cleanliness, flavor, ease of use, eco-friendliness, willingness to switch, satisfaction, texture. This is measured on a Likert Scale from 1-4. 1 represents strongly agree with overall product satisfaction. 4 represents strongly disagree with overall product satisfaction.