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| Name | Class |
|---|---|
| Colgate Palmolive | INDUSTRY |
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This is a clinical investigation to measure the changes in the oral environment resulting from a 3 month exposure to an arginine containing toothpaste. This study is a double blind, randomized controlled, parallel design. Seventy (70) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following oral health evaluations, subjects will be assigned to the treatment schedule and receive their assigned study product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigative Arm- Using an 8% Arginine toothpaste | Experimental | For the study period (12 weeks), subjects in the Investigative Arm will be instructed to brush their teeth with an 8% Arginine toothpaste. |
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| Control Arm- a 1000 ppm F toothpaste | Active Comparator | For the study period (12 weeks), subjects in the Control Arm will be instructed to brush their teeth with Control Arm- a 1000 ppm F toothpaste. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 8% Arginine toothpaste | Device | Investigative |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary pH Impact | The objective of this clinical research study is to determine if the use of an Arginine containing toothpaste alters the salivary pH of people with xerostomia. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring the change in the oral microbiome | The objective of this clinical research study is to determine if the use of an Arginine containing toothpaste alters the oral microbiome (salivary and whole mouth plaque) of people with xerostomia. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Athena Papas, DMD, PhD | Tufts University School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | United States |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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double blinded
| 1000 ppm F toothpaste |
| Drug |
Control |
|