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Completed

NCT Number: NCT05805865

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

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.

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Key information

Conditions

Gingival Inflammation Behavior Consumer Behavior Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Loma Linda University

Loma Linda, California, 92350, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Toothpaste Tablet

Drug

Colgate Anywhere Toothpaste Tablets

Conventional Toothpaste

Drug

Colgate Cavity Protection

Primary outcomes

  1. Plaque Index Score at Baseline

    Time frame: 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.

    • 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.

  2. Gingival Index Score at Baseline

    Time frame: 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.

    • = 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 outcomes

  1. Subject Perception of Product Use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 10, 2023
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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