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

Sponsor
Loma Linda University (Other)
Overall Status
Completed
CT.gov ID
NCT05805865
Collaborator
(none)
40
1
2
20
60.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Toothpaste Tablet
  • Device: Conventional Toothpaste
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Masking Description:
Investigator blinded to group
Primary Purpose:
Prevention
Official Title:
Efficacy of Eco-Friendly Toothpaste Tablets Versus Conventional Toothpaste Using PI and GI Index
Actual Study Start Date :
Jan 3, 2023
Actual Primary Completion Date :
Jan 23, 2023
Actual Study Completion Date :
Jan 23, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Toothpaste Tablet

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

Device: Toothpaste Tablet
Colgate Anywhere Toothpaste Tablets

Active Comparator: Conventional Toothpaste

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

Device: Conventional Toothpaste
Colgate Cavity Protection

Outcome Measures

Primary Outcome Measures

  1. Plaque Index Score [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 [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 Outcome Measures

  1. Subject Perception of Product Use [Visit 2 two weeks post study enrollment]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loma Linda University Loma Linda California United States 92350

Sponsors and Collaborators

  • Loma Linda University

Investigators

  • Principal Investigator: So Ran Kwon, DDS, MS, PhD, Loma Linda University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
So Ran Kwon, Professor, Loma Linda University
ClinicalTrials.gov Identifier:
NCT05805865
Other Study ID Numbers:
  • 5220342
First Posted:
Apr 10, 2023
Last Update Posted:
Apr 10, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by So Ran Kwon, Professor, Loma Linda University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 10, 2023