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| Name | Class |
|---|---|
| Gaba International AG | INDUSTRY |
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The purpose of this study is to determine whether rinsing with an amine fluoride/stannous flouride mouthrinse in addition to daily tooth brushing is more effective than tooth brushing alone.
Gingivitis prevalence is 100% among the population. This is mostly due to an inadequate mechanical cleaning of the teeth. However, remaining dental biofilm can be approached by antibacterial mouthrinses. As a consequence of regular use of these mouthrinses, gingivitis can be reduced. Amine fluoride/stannous flouride mouthrinse (ASF)has proved its efficacy in several studies. In the previous years, a new formulation that does not contain ethanol anymore was introduced in the market. Therefore, it is the aim of the study to proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone. In addition, effects on dental plaque, discoloration of teeth and bacterial colonization should be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amine fluoride/stannous fluoride | Experimental | Amine fluoride/stannous fluoride mouthrinse in addition to mechanical oral hygiene |
|
| No rinsing | No Intervention | Mechanical oral hygiene only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amine fluoride/stannous fluoride | Drug | 10 ml qd, oral, topical, 6 months duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in gingivitis | To proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in plaque | To proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on plaque reduction than mechanical oral hygiene alone. | 6 months |
| Discoloration of teeth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Hoffmann, Prof. Dr. | Technische Universität Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie | Dresden | Saxony | 01109 | Germany |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D014002 | Tin Fluorides |
| C059813 | Meridol |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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To proof the effect of rinsing with ASF on discoloration of teeth
| 6 months |
| Bacterial colonization | To proof whether rinsing with ASF adjunctive to mechanical oral hygiene influences bacterial colonization | 6 months |
| Adverse events | Recording all adverse events over the entire rinsing period | 6 months |
| D009057 |
| Stomatognathic Diseases |
| D017971 |
| Tin Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |