Clinical Trial for Evaluating Sage-Based Mouthrinse
關鍵詞
抽象
描述
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.
日期
| 最後驗證: | 04/30/2018 |
| 首次提交: | 06/30/2016 |
| 提交的預估入學人數: | 07/07/2016 |
| 首次發布: | 07/12/2016 |
| 上次提交的更新: | 04/30/2018 |
| 最近更新發布: | 05/01/2018 |
| 實際學習開始日期: | 09/30/2016 |
| 預計主要完成日期: | 09/30/2017 |
| 預計完成日期: | 03/31/2018 |
狀況或疾病
干預/治療
Other: Group A
Other: Group B
相
手臂組
| 臂 | 干預/治療 |
|---|---|
| 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. |
資格標準
| 有資格學習的年齡 | 18 Years 至 18 Years |
| 有資格學習的性別 | All |
| 接受健康志願者 | 是 |
| 標準 | 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 - |
結果
主要結果指標
1. Sulcus Bleeding Index [six weeks]
