Clinical Trial for Evaluating Sage-Based Mouthrinse
Lykilorð
Útdráttur
Lýsing
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.
Dagsetningar
| Síðast staðfest: | 04/30/2018 |
| Fyrst lagt fram: | 06/30/2016 |
| Áætluð skráning lögð fram: | 07/07/2016 |
| Fyrst sent: | 07/12/2016 |
| Síðasta uppfærsla lögð fram: | 04/30/2018 |
| Síðasta uppfærsla sett upp: | 05/01/2018 |
| Raunverulegur upphafsdagur náms: | 09/30/2016 |
| Áætlaður aðallokunardagur: | 09/30/2017 |
| Áætlaður dagsetningu rannsóknar: | 03/31/2018 |
Ástand eða sjúkdómur
Íhlutun / meðferð
Other: Group A
Other: Group B
Stig
Armhópar
| Armur | Íhlutun / meðferð |
|---|---|
| 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. |
Hæfniskröfur
| Aldur hæfur til náms | 18 Years Til 18 Years |
| Kyn sem eru hæf til náms | All |
| Tekur við heilbrigðum sjálfboðaliðum | Já |
| Viðmið | 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 - |
Útkoma
Aðal niðurstöður ráðstafanir
1. Sulcus Bleeding Index [six weeks]
