Clinical Trial for Evaluating Sage-Based Mouthrinse
Märksõnad
Abstraktne
Kirjeldus
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.
Kuupäevad
| Viimati kinnitatud: | 04/30/2018 |
| Esmalt esitatud: | 06/30/2016 |
| Hinnanguline registreerumine on esitatud: | 07/07/2016 |
| Esmalt postitatud: | 07/12/2016 |
| Viimane värskendus on esitatud: | 04/30/2018 |
| Viimati värskendus postitatud: | 05/01/2018 |
| Õppe tegelik alguskuupäev: | 09/30/2016 |
| Eeldatav esmane lõpetamise kuupäev: | 09/30/2017 |
| Eeldatav uuringu lõpetamise kuupäev: | 03/31/2018 |
Seisund või haigus
Sekkumine / ravi
Other: Group A
Other: Group B
Faas
Käerühmad
| Arm | Sekkumine / ravi |
|---|---|
| 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. |
Abikõlblikkuse kriteeriumid
| Õppimiseks sobivad vanused | 18 Years To 18 Years |
| Uuringuks kõlblikud sood | All |
| Võtab vastu tervislikke vabatahtlikke | Jah |
| Kriteeriumid | 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 - |
Tulemus
Esmased tulemusnäitajad
1. Sulcus Bleeding Index [six weeks]
