Trial document




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  DRKS00017128

Trial Description

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Title

Oral Health of Centenarians

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

More and more people reach the old age of 100 years and older. So far, however, little is known about oral health, possible age-related changes or special dental problems in this age group. Therefore, the aim of this study is a first-time examination of the oral and dental health, the salivary flow, the oral microbiome and oral health related quality of life in elders above the age of 100 years.

For the purpose of the study, subjects aged 100 years or older are questioned about their oral health and subsequently receive a dental examination. This appointment can take place as a home visit by a dentist participating in the study, or at the premises of the Department of Conservative Dentistry, Clinic for Oral, Dental and Maxillofacial Diseases, University Hospital Heidelberg, Germany. The interview contains questions about dental appointments, habits of oral hygiene and satisfaction with the current state of oral and dental health. The subsequent examination corresponds to a dental check-up. In addition, the salivary flow rate is determined, and a sample of saliva and plaque is taken.

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Brief Summary in Scientific Language

In the context of changing demography, old and very old people are becoming increasingly important in medicine and society. The longevity and health of centenarians are of great interest, which has led to a number of publications in many sociological and medical disciplines.
In the field of dentistry, however, the level of knowledge is extremely low. Due to this lack of data, this project aims to conduct a cross-sectional study of the oral status, salivary flow rate, oral microbiome and the oral health-related quality of life in centenarians and to compare them to results from similar birth cohorts. For this purpose, participants are invited to an interview, as well as to a dental examination. Furthermore, a sample of saliva and plaque is taken.

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Organizational Data

  •   DRKS00017128
  •   2019/05/20
  •   [---]*
  •   yes
  •   Approved
  •   S-168/2019, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K02 -  Dental caries
  •   K05 -  Gingivitis and periodontal diseases
  •   K13 -  Other diseases of lip and oral mucosa
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Interventions/Observational Groups

  •   Patients aged 100 years and older (cross-sectional study of the oral status, salivary flow rate, oral microbiome and the oral health-related quality of life)
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Outcome criteria
1. oral health indexes
• DMFT/DMFS-Index:
• Dental erosion: Following the Basic Erosive Wear Examination (BEWE)
• Root Caries Indexes (RCI)
• Periodontal parameters: Bleeding on Probing (BOP), CDC/AAP-classifications, Community Periodontal Index (CPI, without Treatment Needs [TN])
• type of prosthetic restoration (according to Kerschbaum)
• Dental functional capacity (according to Nitschke)
• Salivatory flow rate

2. Geriatric Oral Health Assessment Index (GOHAI) (German version)

3. Microbiome analysis (16S rRNA amplicon sequencing)

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Secondary Outcome

explorative study, see primary outcome criteria

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/06/03
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- the study participant is age 100 years or older
- the study participant is able to give consent

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Exclusion Criteria

- Patients missing one or more requirements in the inclusion criteria
- Patients with incomplete consent form

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Addresses

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    • Poliklinik für Zahnerhaltungskunde, Klinik für Mund-, Zahn- und Kieferkrankheiten des Universitätsklinikums Heidelberg
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    •   +496221/5639886
    •   [---]*
    •   [---]*
    •   [---]*
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    • Poliklinik für Zahnerhaltungskunde der Klinik für Mund-, Zahn- und Kieferkrankheiten des Universitätsklinikums Heidelberg
    • Ms.  Dr.  Caroline  Sekundo 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    • Poliklinik für Zahnerhaltungskunde der Klinik für Mund-, Zahn- und Kieferkrankheiten des Universitätsklinikums Heidelberg
    • Ms.  Dr.  Caroline  Sekundo 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Poliklinik für Zahnerhaltungskunde der Klinik für Mund-, Zahn- und Kieferkrankheiten des Universitätsklinikums Heidelberg
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    •   +496221/5639886
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Enrolling by invitation
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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.