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This clinical multi-center, controlled, study will be carried out in volunteers with every 3- to 6-months professional tooth cleaning during their non-treatment period between 2 re-calls of a supportive periodontitis therapy regime. The efficacy of domestic oral hygiene by using a commercial dentifrice will be determined. Besides regularly used ingredients such as NaF and cleaning bodies the dentifrice contains a novel compound, which may be beneficial for the protection of an eubiotic oral microbiome. During the 3-month study period, participants will brush with their allocated study product twice daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| toothpaste | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toothpaste | Other | brushing teeth with toothpaste twice a day for and refrain from mouth rinsing after spitting out |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy before and after 3 months of using newly developed microbiome-modulating toothpaste | From enrollment to the end of treatment at 12 weeks. |
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Inclusion Criteria:
At Screening (Visit 1):
Exclusion Criteria:
Medication exclusions at screening (Visit 1):
Periodontal and dental exclusions:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Hofmann | Not yet recruiting | Bietigheim-Bissingen | 74321 | Germany |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014100 | Toothpastes |
| ID | Term |
|---|---|
| D003802 | Dentifrices |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Dr. T. Schütz | Recruiting | Borna | 04552 | Germany |
|
| Dr. G. Jungbauer | Recruiting | Straubing | 94315 | Germany |
|