Clinical Trial for Evaluating Sage-Based Mouthrinse
Sleutelwoorden
Abstract
Omschrijving
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.
Datums
| Laatst geverifieerd: | 04/30/2018 |
| Eerste ingediend: | 06/30/2016 |
| Geschatte inschrijving ingediend: | 07/07/2016 |
| Eerst geplaatst: | 07/12/2016 |
| Laatste update ingediend: | 04/30/2018 |
| Laatste update geplaatst: | 05/01/2018 |
| Werkelijke startdatum van het onderzoek: | 09/30/2016 |
| Geschatte primaire voltooiingsdatum: | 09/30/2017 |
| Geschatte voltooiingsdatum van het onderzoek: | 03/31/2018 |
Conditie of ziekte
Interventie / behandeling
Other: Group A
Other: Group B
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| 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. |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 18 Years Naar 18 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| Criteria | 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 - |
Resultaat
Primaire uitkomstmaten
1. Sulcus Bleeding Index [six weeks]
