Trial document




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  DRKS00018779

Trial Description

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Title

Efficacy of brushing teeth in patients with reduced oral hygiene by trained non-dental staff - a randomized controlled intervention trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In the trial it should be shown that once trained non-dental personnel compared to dental trained staff by patients with impaired oral hygiene by foreign cleaning gets an equally good cleaning result when foreign persons are brushing the patients teeth, both when using a conventional manual toothbrush as well an electric toothbrush.

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Brief Summary in Scientific Language

This randomized controlled intervention trial aims to demonstrate that once-trained non-dental staff will achieve the same level of cleaning performance (shown by improved plaque indices) by patients with reduced oral hygiene as compared to dental staff by patients with reduced oral hygiene by staining both when using a conventional manual toothbrush as well as an electric toothbrush.

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Organizational Data

  •   DRKS00018779
  •   2019/11/04
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  •   yes
  •   Approved
  •   19-1407, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   K05.1 -  Chronic gingivitis
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Interventions/Observational Groups

  •   dentist-trained staff using manual toothbrushes and interdental space brushes, brush once for a maximum of 6 minutes
  •   Dental trained staff using electric toothbrushes and interdental space brush, brush once for a maximum of 6 minutes
  •   trained non-dental staff using manual toothbrushes and interdental space brushes, brush once for a maximum of 6 minutes
  •   trained non-dental staff using electric toothbrushes and interdental space brushes, brush once for a maximum of 6 minutes
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The aim is to show that non-dental trained staff compared to dental trained staff by patients with impaired oral hygiene by foreign cleaning gets the same good cleaning result (shown by improved plaque indices) when foreign teeth brushing the patient, both when using a conventional manual toothbrush as well as an electric toothbrush.
The primary target during the trial is the oral hygiene indices before and after brushing, such as QHI (0-5), / PBI / GI / MPI (fullmouth).
About 12 months are planned for the complete trial duration.

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Secondary Outcome

Self-awareness, self-assessment of the cleaners, self-consciousness, assessment of the result, satisfaction of the cleaned
Further outcome parameters using VAS scales and the time taken for the duration of the cleaning are considered, survey of time, duration of cleaning and willingness-to-pay (Time is stopped via the dental chair located stopwatch)
In addition, a survey is carried out both of the plasterers and the cleansers, where an estimate of the process quality and the quality of the result of the plastering is mapped using Lickert scales.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/11/14
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients of the policlinic for periodontology and operative dentistry University hospital of Cologne and course patients in the periodontics course who come to the clinic for PA initial therapy in the context of medical care
A written consent of the patient in the study Patients who had reduced oral hygiene at the beginning of PA initial therapy with a Quigley-Hein index of> 1.5 and at least 4 remaining teeth to have.

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Exclusion Criteria

Foreseeable loss of residual dentition due to already diagnosed inflammations / relaxations, as well as patients with toothless jaw

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Addresses

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    • Universitätsklinikum - Köln (AöR)
    • 50924   Köln
    • Germany
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    • Poliklinik für Zahnerhaltung und Parodontologie der Uniklinik Köln.
    • Ms.  Dr. Dr.  Greta  Barbe 
    • Kerpenerstraße 32
    • 50937  Köln
    • Germany
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    • Poliklinik für Zahnerhaltung und Parodontologie der Uniklinik Köln
    • Ms.  Dr. Dr.  Greta  Barbe 
    • Kerpenerstraße 32
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Poliklinik für Zahnerhaltung und ParodontologieUniklinik Köln
    • Kerpener Strasse 32
    • 50931  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.