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Investigation of the cleaning efficacy of commercial orthodontic cleaning tablets regarding biofilm removal on PMMA test specimens ? an in vivo study

Investigation of the cleaning efficacy of commercial orthodontic cleaning tablets regarding biofilm removal on PMMA test specimens ? an in vivo study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024882
Enrollment
20
Registered
2021-04-14
Start date
2021-04-22
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K05 K02

Interventions

Group 1: Dontodent cleaning tablets (Propack GmbH) One cleaning tablet will be used to investigate one PMMA specimen. A cleaning tablet will be dropped into 150 ml warm water and the PMMA specimen wi

Sponsors

Charité - Universitätsmedizin Berlin ChariteCentrum für Zahn-, Mund- und Kieferheilkunde (CC 3)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactAlice Arndt

Charité - Universitätsmedizin Berlin

alice.arndt@charite.de01707222410

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026