Healthy patients
Conditions
Interventions
Group 1: In a randomized study with a four-replicate cross-over design, two lozenges containing the complete LPO-system with 0.083%H2O2(B)/0.04%H2O2(C) and thiocyanate were compared with an essential
total, S. mutans and Lactobacilli) were assessed.
Group 2: Test-Lozenge: complete LPO-System with 0.083% H2O2
Test-Lozenge: complete LPO-System with 0.04% H2O2
Positive Control: essential oil mouth rinse
Negative Control: Placebo-lozenge
Sponsors
Zentrum für Zahn-, Mund- und Kieferheilkunde der Universitätsmedizin Greifswald
Eligibility
Sex/Gender
All
Age
18 Years to 30 Years
Inclusion criteria
Inclusion criteria: female and male subjects who are at least 18 years old • Present written declaration of consent • Willingness and ability to meet the study requirements • No systemic diseases, no use of antibiotics or medication in the last 6 months that would influence the Polymorphonuclear leukocytes function and/or salivary gland function and the salivary and sulcular fluid composition. • No periodontal treatment in the last 6 months • No pregnancy and breastfeeding • No simultaneous participation in another clinical trial • No smokers, alcohol, medication or drug addicts
Exclusion criteria
Exclusion criteria: • Taking antibiotics • Pregnancy and breast-feeding period • Simultaneous participation in another clinical trial • lack of compliance • Alcoholics, smokers, drug and drug addicts • known hypersensitivity or allergies to the ingredients used in the chewing tablet, e.g. milk allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plaque inhibition: According to the 4-day plaque regrowth study design, on day 5, the plaque regrowth is assessed with a disclosing solution (MIRA-2-TON®, Hager & Werken GmbH, Germany) and scored using Quigley & Hein plaque index (QHI) modified by Turesky et al. 1970. | — |
Secondary
| Measure | Time frame |
|---|---|
| Antimicrobial effectivity: According to the 4-day plaque regrowth study design, on day 5, plaque assays are taken from the buccal surfaces of the first and third quadrant, and the palatinal/lingual surfaces of the second and fourth quadrant, respectively. All assays of each subject are pooled before processing for the microbiological analysis. The antibacterial effect is assessed by the determination of colony-forming units (CFU; S. mutans, Lactobacilli and total bacterial count). The isolation and differentiation of the pathogens S. mutans and Lactobacilli took place semiquantitatively from the plaque obtained by means of the commercially available CRT caries risk test (Ivoclar-Vivadent, Lichtenstein). For this purpose, a sample of the plaque is transferred to a vial. The plaque was determined by weighing and suspended in 0.9% NaCl. 50 µl of the plaque suspension were pipetted onto the CRT test strip in a 1:10 dilution. After 48 h of incubation at 37 °C, the colonies are counted. The total bacterial count is determined on the basis of the German Industry Standard (DIN EN ISO 6222) on tryptone soy agar after 48-72 h incubation at 36 °C. | — |
Countries
Germany
Contacts
Public ContactAlexander Welk
Poliklinik für Zahnerhaltung, Parodontologie, Endodontologie, Präventive Zahnmedizin und Kinderzahnheilkunde im Zentrum für Zahn-, Mund- und Kieferheilkunde der Universitätsmedizin der Ernst-Moritz-Arndt Universität Greifswald
Outcome results
None listed