K05 K02
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. subject/participant is willing to wear a vacuum-formed splint for seven days 2. subject/participant is = 18 years old 3. subject/participant is capable of consenting independently.
Exclusion criteria
Exclusion criteria: 1. removable prothesis or removable orthodontic appliances (upper jaw) 2. less than four molars in the upper jaw 3. topical application of fluoride gel, fluoride solution, fluoride varnish, Tooth Mousse® CHX (chlorhexidine) or Listerine® 4. children/ adolescents, young people under 18 years old 5. person with intellectual disabilities 6. active dental caries 7. periodontitis 8. infectious diseases (HIV, Hepatitis) 9. epilepsy 10. immunosuppression 11. antibiotic intake 12. allergies to PMMA/MMA 13. severe gag reflex 14. chewing gums
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary hypothesis: Chemical cleaning alone with commercial orthodontic cleaners will result in sufficient cleaning performance for a mature biofilm. The null hypothesis that the cleaning efficacy is below 75% will be tested. Main parameter: 100 x ( (OPA uncleaned - OPA cleaned) / OPA cleaned). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary hypothesis: Comparison of the mean cleaning efficacy of the three orthodontic cleaning tablets. Null hypothesis: There is no difference in the cleaning efficacy of the three orthodontic cleaners. | — |
Countries
Germany
Contacts
Charité - Universitätsmedizin Berlin