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The objective of this study is to evaluate the anticaries efficacy for three dentifrices (1.5% arginine in a calcium base, 8.0% arginine in a calcium base, and 0.32% sodium fluoride in a silica base) in a two-year caries clinical study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.32% Sodium Fluoride Dentifrice Toothpaste | Active Comparator | Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study |
|
| 1.5% Arginine Dentifrice Toothpaste | Experimental | Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study |
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| 8.0% Arginine Dentifrice Toothpaste | Experimental | Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.32% Sodium Fluoride Dentifrice Toothpaste | Drug | Toothpaste |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces score after 2 year product use. | the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome | 2 year |
| The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Teeth scores after two year of product use. | the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome | 2 year |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yun Po E Zhang, PhD, DDS(Hons) | Colgate Palmolive | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Stomatology, Xian Jiaotong University | Xi'an | Shaanxi | 710004 | China | ||
| West China School of Stomatology, Sichuan University |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| 1.5% Arginine Dentifrice | Drug | Toothpaste |
|
| 8.0% Arginine Dentifrice | Drug | Toothpaste |
|
| Chengdu |
| Sichuan |
| 610041 |
| China |
| School of Stomatology Chongqing Medical University | Chongqing | 400016 | China |