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Qualified subjects will be enrolled and randomized to either one of the two study groups described above based on their initial modified gingivitis and plaque scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after two weeks, six weeks and three months of product use. All subjects will be followed for adverse events throughout the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 mouthwash | 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 each mouthwash rising. Each qualified subject will follow this specific application for 3 months |
|
| Test 2 mouthwash | Active Comparator | After brushing either in the morning or in the evening, 20 ml of the mouthwash shall be used for each rinsing, 2 times daily (morning and evening) for 30 seconds each time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride Mouthwash | Drug | 0.09% CPC, 0.28% zinc lactate and 500 ppm F as sodium fluoride |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Gingival Index | A Modified Gingivitis Index score from 0 to 4 will be assigned by the examiner to all tooth surfaces. In regards to the scale, lower number is a better outcome. | baseline, 2 week, 6 week & 3 month |
| Saxton Bleeding Index | Gingival bleeding is assessed 30 seconds after probing; a score of 0 represents an absence of bleeding. a score of 1 is given if bleeding is observed within 30 seconds after probing and a score of 2 is given if bleeding is observed immediately on probing | baseline, 2 week, 6 week & 3 month |
| Modified Quigley-Hein Plaque Index | Modified Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed tooth surfaces. In regards to the scale, lower number is a better outcome. | baseline, 2 week, 6 week & 3 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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| sodium fluoride Mouthwash | Drug | 100 ppm F as sodium fluoride |
|
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
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| ID | Term |
|---|---|
| D002594 | Cetylpyridinium |
| C015101 | cytidylyl-(3'-5')-cytidine |
| ID | Term |
|---|---|
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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