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The objective of this six-month clinical research study is to evaluate the clinical efficacy of a new mouthwash on helping prevent gum problems (gingival index scores ) in adults as compared to a control mouthwash.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Mouthwash containing CPC, Zinc and Hyaluronic acid | Experimental | After brushing in the morning and in the evening, 20 ml of mouthwash shall be used for each rinsing, 2 times daily (morning and evening ) for 30 seconds each time. No further rinsing with water shall be occurred after spilt out and after each mouthwash rising. Each qualified subject will follow this specific application for 6 months |
|
| Fluoride Mouthwash | Active Comparator | After brushing in the morning, 10 ml of mouthwash shall be used for each rinsing, 1 time daily (morning ) for 60 seconds each time. No further rinsing with water shall be occurred after spilt out and after each mouthwash rising. Each qualified subject will follow this specific application for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash | Drug | 0 .075 % cetylpyridinium chloride and 0 .28 % zinc lactate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mombelli Modified Gingival Index | Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival | baseline |
| Mombelli Modified Gingival Index | Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival | three month |
| Mombelli Modified Gingival Index | Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival | six month |
| Mombelli Modified Plaque Index | Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque | baseline |
| Mombelli Modified Plaque Index | Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque | three month |
| Mombelli Modified Plaque Index | Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque | six month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Montesani, DDS | University of Rome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Odontoiatrica Montesani | Roma | Rome | 00187 | Italy |
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| PhosFlur Mouthwash | Drug | 0 .044 % sodium fluoride |
|
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002594 | Cetylpyridinium |
| ID | Term |
|---|---|
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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