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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toothpaste Tablet | Experimental | Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes. |
|
| Conventional Toothpaste | Active Comparator | Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toothpaste Tablet | Drug | Colgate Anywhere Toothpaste Tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Index Score at 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.
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 at 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.
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Perception of Product Use | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| So Ran Kwon, DDS, MS, PhD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92350 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Toothpaste Tablet | Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes. Toothpaste Tablet: Colgate Anywhere Toothpaste Tablets |
| FG001 | Conventional Toothpaste | Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes. Conventional Toothpaste: Colgate Cavity Protection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Toothpaste Tablet | Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes. Toothpaste Tablet: Colgate Anywhere Toothpaste Tablets |
| BG001 | Conventional Toothpaste |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plaque Index Score at 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.
Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth. | Posted | Mean | Standard Deviation | Score on a scale | Change between baseline at visit 1 and visit 2, two weeks post baseline. |
|
Two weeks post-baseline
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Toothpaste Tablet | Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes. Toothpaste Tablet: Colgate Anywhere Toothpaste Tablets |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor, Director of Student Research | Loma Linda University Health | 909 558 5118 | sorankwon@llu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2022 | May 3, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D003258 | Consumer Behavior |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D014100 | Toothpastes |
| ID | Term |
|---|---|
| D003802 | Dentifrices |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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Investigator blinded to group
| Conventional Toothpaste |
| Drug |
Colgate Cavity Protection |
|
| Visit 2 two weeks post study enrollment |
Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes.
Conventional Toothpaste: Colgate Cavity Protection
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Toothpaste Tablet |
Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes. Toothpaste Tablet: Colgate Anywhere Toothpaste Tablets |
| OG001 | Conventional Toothpaste | Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes. Conventional Toothpaste: Colgate Cavity Protection |
|
|
| Primary | Gingival Index Score at 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.
Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth. | Posted | Mean | Standard Deviation | Score on a scale | 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. 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. | Posted | Mean | Standard Deviation | units on a scale | Visit 2 two weeks post study enrollment |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Conventional Toothpaste | Subjects are instructed to use the toothpaste for brushing. Brushing is recommended twice daily for two minutes. Conventional Toothpaste: Colgate Cavity Protection | 0 | 20 | 0 | 20 | 0 | 20 |
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| D009057 |
| Stomatognathic Diseases |
| D001519 | Behavior |