no disease: oral hygiene
Conditions
Interventions
Group 1: 40 partially randomized (stratified according to gender and age) assigned subjects use the test toothpaste, in a period of 8 weeks (2 minutes twice a day).
Group 2: 40 partially randomized
Sponsors
Universität Witten/HerdeckeFakultät für GesundheitDepartment für Zahn-, Mund- und KieferheilkundeAbt. für Zahnerhaltung und Präventive Zahnmedizin
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactStefan Prof. Dr. Zimmer
Universität Witten/Herdecke Fakultät für Gesundheit Department für Zahn-, Mund- und Kieferheilkunde Abt. für Zahnerhaltung und Präventive Zahnmedizin
Outcome results
None listed