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The purpose of this study is to prove whether a fluoride/zinc lactate containing mouthrinse is able to reduce dental plaque and gingival inflammation in patients who have gingivitis when applied twice daily during brushing at home over a period of 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mouthwash Test | Active Comparator |
| |
| Mouthwash Experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amine/zinc lactate/fluoride system | Drug | Amine/zinc lactate/fluoride system (250 ppm F), meridol®, Colgate-Palmolive |
|
| Measure | Description | Time Frame |
|---|---|---|
| Whole-mouth Mean Modified Gingival Index (MGI) | Gingivitis, gingival severity and gingival, interproximal scores as measured by the Gingival Index as difference from baseline to 24 weeks between the study groups. | Baseline, 3 weeks, 12 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Turesky Modification of the Quigley Hein Plaque Index (PI) | Plaque, plaque severity and plaque interproximal scores as measured by the Plaque Index as difference from baseline to 24 weeks between the study groups and at each time-point. | Baseline, 3 weeks, 12 weeks, 24 weeks |
| Intraoral scans |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technische Universität Dresden | Dresden | 01307 | 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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| negative control | Drug | Sodium fluoride mouthwash 250 ppm |
|
Quantitative changes & before/after imagery from intraoral scans |
| Baseline, 3 weeks, 12 weeks, 24 weeks |
| Patient-reported experiences | Changes in participant-reported experience as determined through participant-questionnaire | Baseline, 3 weeks, 12 weeks, 24 weeks |
| D009057 |
| Stomatognathic Diseases |