Effectiveness of an Echinacea toothpaste in relation to biofilm and gingivitis - a clinical study
- Conditions
- no disease: oral hygiene
- Registration Number
- DRKS00034224
- Lead Sponsor
- niversität Witten/HerdeckeFakultät für GesundheitDepartment für Zahn-, Mund- und KieferheilkundeAbt. für Zahnerhaltung und Präventive Zahnmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 80
At least 16 uncrowned teeth
- Papilla bleeding index = 0.5
- Quigley-Hein index (modified according to Turesky) = 2
- Existing informed consent for participation in the study
- Pregnancy and breastfeeding or planning a pregnancy during the study period
- Uncontrolled diabetes (type I and II)
- Existing removable dentures
- Fixed or removable orthodontic appliance
- Aggressive or severe chronic periodontitis
- Previous participation in the study
- Participation in another clinical study or use of another product to be tested within the last 30 days before the first examination
- Use of antibiotics within the last 14 days before the first examination or other medication or the presence of a therapy that could influence the study results.
- Known or suspected allergy to one or more ingredients of the toothpaste
- Alcohol or drug abuse within one year before the start of the first examination
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the PBI (Papillary Bleeding Index) as an expression of the quality of oral hygiene. This is going to be checked in the initial, intermediate and final examination by measuring the gum resistance using a blunt probe. The value is measured for each tooth (except wisdom teeth) an noted on the sheet afer each examination.
- Secondary Outcome Measures
Name Time Method Change in mAPI (modified approximal plaque index) and mQHI (modified Quigley-Hein plaque index) as an expression of the quality of oral hygiene results Questionnaire. These are going to be checked in the initial, intermediate and final examination, after the teeth are stained with a non-persistent solution (Mira 2-Tone), so that the plaque can be visualized. The value is measured for each tooth (except wisdom teeth) an noted on the sheet afer each examination.