Clinical Trial for Evaluating Sage-Based Mouthrinse
Keywords
Coimriú
Cur síos
A sage-based mouthrinse based on an extract from Salvia officinalis in a composition with extracts from Althaea Officinalis, Aesculus Hippocatanum Bark and essential oils might comprise an alternative to conventional antimicrobial mouthrinses, which might exhibit important side effects. Thus the aim of the current study is to test the null-hypothesis H0:
A sage-based mouthrinse (Dr. Hauschka Med, Mundspülung Salbei, WALA Heilmittel GmbH, Dorfstraße 1, 73087 Bad Boll/Eckwälden, Germany) is less or equal effective in alleviating inflammatory signs of intra-oral mucosa and gingiva than an water/alcohol-based taste adjusted placebo.
The placebo and the sage-based mouthrinse will be manufactured according to EU-Kosmetik-Verordnung 1223/2009 and provided by WALA Heilmittel GmbH, Dorfstraße 1, 73087 Bad Boll/Eckwälden, Germany together with the necessary safety documentation. The placebo will be an alcohol/ water based solution with a similar taste to the tested mouthrinse.
The main outcome parameter will be Sulcus Bleeding Index SBI. Among others, the main secondary outcome parameters will be Oral Health Related Quality of Life as assessed with the OHIP-14 G questionnaire, the Xerostomia inventory and a Tooth staining index.
Dátaí
| Fíoraithe Deireanach: | 04/30/2018 |
| Cuireadh isteach den chéad uair: | 06/30/2016 |
| Clárú Measta Curtha isteach: | 07/07/2016 |
| Arna chur suas ar dtús: | 07/12/2016 |
| Nuashonrú Deireanach Curtha isteach: | 04/30/2018 |
| Nuashonrú Deireanach Postáilte: | 05/01/2018 |
| Dáta Tosaigh an Staidéir Iarbhír: | 09/30/2016 |
| Dáta Críochnaithe Bunscoile Measta: | 09/30/2017 |
| Dáta Críochnaithe an Staid Mheasta: | 03/31/2018 |
Coinníoll nó galar
Idirghabháil / cóireáil
Other: Group A
Other: Group B
Céim
Grúpaí Láimhe
| Lámh | Idirghabháil / cóireáil |
|---|---|
| Experimental: Group A Active Agent | Other: Group A Supervised use over 6 weeks 1x/day additional to habitual oral hygiene protocol.
For an application fill the closure cap with the mouthwash. Rinse the mouth vigorously for 30 seconds, for easier timekeeping use the hourglass. Then spit out the mouthwash, do not rinse. |
| Placebo Comparator: Group B Placebo | Other: Group B Supervised use over 6 weeks 1x/day additional to habitual oral hygiene protocol.
For an application fill the closure cap with the mouthwash. |
Critéir Incháilitheachta
| Aois Incháilithe le haghaidh Staidéir | 18 Years Chun 18 Years |
| Gnéas Incháilithe le haghaidh Staidéir | All |
| Glacann Oibrithe Deonacha Sláintiúla | Sea |
| Critéir | Inclusion Criteria: - Able to give informed consent, i.e. no legal guardian appointed - Willing to participate - Depended on their ADLs (IADL)(24) - Sulcus Bleeding Index (SBI) > 50% Exclusion Criteria: - Allergy to one of the components - Edentulous - Alcohol dependency - Prescription of antibiotics and/ or immunosuppressives (e.g. glucocorticoids) Anti-inflammatory mouthrinse - |
Toradh
Bearta Toraidh Príomhúla
1. Sulcus Bleeding Index [six weeks]
