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Objectives: To evaluate the effectiveness of toothpaste tablets when compared to conventional dentifrices in removing plaque.
Methods: 50 participants are randomized into two groups: Denttabs toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (P). Both groups utilize their assigned dentifrice for 6 weeks. A pre and post-assessment measures the Gingival Index (GI) and Plaque Index (PI) and Decayed, Missing and Filled Teeth (DMFT). A questionnaire on the use of the product is distributed at the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toothpaste Tablet | Experimental | Subjects are instructed to use one toothpaste tablet at each brushing. Brushing is recommended twice daily for two minutes. |
|
| Conventional Toothpaste | Active Comparator | Subjects are instructed to use the toothpaste at each brushing. Brushing is recommended twice daily for two minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toothpaste Tablet | Drug | Denttabs toothpaste tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Index Score at Baseline | The quantity of plaque build-up is measured visually using the Quigley-Hein Plaque Index. The Plaque index can range from 0 to 5, with higher numbers indicating more plaque build-up. | Change between baseline at visit 1 and visit 2, six weeks post baseline |
| Gingival Index Score at Baseline | The severity of gingival inflammation is measured visually using the Loe-Silness Gingival Index. Gingival index can range from 0 to 3, with higher numbers indicating more gingival inflammation. | Change between baseline at visit 1 and visit 2, six weeks post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| DMFT Score at Baseline | Caries experiences is measured visually using the DMFT index. DMFT score can range from 0 to 28, with higher numbers indicating higher caries experiences. | Change between baseline at visit 1 and visit 2, six weeks post baseline |
| Subject Perception of Product Use |
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Inclusion Criteria:
Exclusion Criteria:
1. Subjects under the age of 18.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| So Ran Kwon, DDS, MS, PhD | Contact | 909 558 5118 | 55118 | sorankwon@llu.edu |
| Name | Affiliation | Role |
|---|---|---|
| So Ran Kwon, DDS, MS, PhD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Health | Loma Linda | California | 92350 | United States | ||
| Loma Linda University |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D003731 | Dental Caries |
| 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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| Conventional Toothpaste | Drug | Colgate Cavity Protection toothpaste |
|
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The perception on the product usage is measured using a survey containing questions on feel, texture, flavor, ease of use, eco-friendliness, cost and overall satisfaction. Response is on a 4 point Likert scale ranging from strongly agree (1) to strongly disagree (4). |
| Visit 2 six weeks post study enrollment |
| Loma Linda |
| California |
| 92350 |
| United States |
| D009057 |
| Stomatognathic Diseases |
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D001519 | Behavior |