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

Study Overview
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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.

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

Conditions
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Gingival Inflammation

Intervention / Treatment
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* Device: Toothpaste Tablet
* Device: Conventional Toothpaste


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toothpaste Tablet<br>Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes. | Device: Toothpaste Tablet<br>* Colgate Anywhere Toothpaste Tablets<br>|
| Active Comparator: Conventional Toothpaste<br>Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes. | Device: Conventional Toothpaste<br>* Colgate Cavity Protection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingival Index, Plaque Index, Dentifrice, Toothpaste Tablets, Consumer Satisfaction