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The purpose of this study is to evaluate and compare plaque removal efficacy of four dentifrices following a single timed tooth brushing. Prior to each evaluation visit of the four-way cross-over study, subjects will abstain from all oral hygiene for 24 hours. At each evaluation visit, subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.
This study is a randomized, single-brushing, examiner-blinded, 4-cell cross-over design that enrolled approximately 70 subjects to ensure that at least 60 subjects to complete the study. This 4-week cross-over study will evaluate plaque removal following a single brushing with the assigned dentifrices. Qualified subjects will have sufficient plaque (Lobene-Soparkar Modification of Turesky Plaque Index). Subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toothpaste 1 with Stannous Fluoride | Active Comparator | Toothpaste with Stannous Fluoride |
|
| Toothpaste 1 with Sodium Fluoride and sodium bicarbonate | Active Comparator | Toothpaste with Sodium Fluoride and sodium bicarbonate |
|
| Toothpaste 2 with Stannous Fluoride | Active Comparator | Toothpaste with Stannous Fluoride |
|
| Toothpaste 2 with sodium Fluoride and sodium bicarbonate | Active Comparator | Toothpaste with sodium Fluoride and sodium bicarbonate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dentifrices | Drug | Dentifrice on plaque |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured. | plaque evaluation | up to 4 weeks |
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Inclusion Criteria:
1) 18 to 69 years
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research, Inc. | Fort Wayne | Indiana | 46825 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 19, 2021 | May 11, 2021 | 1 | ||
| Jul 27, 2021 |
| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D003802 | Dentifrices |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D003358 | Cosmetics |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| Aug 20, 2021 |
| 2 |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |