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Oral Health, Bite Force and Dementia (OrBiD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775772
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
Study aims: The primary aim is to identify influencing variables on oral hygiene / oral health and bite force in patients with dementia.

Condition or disease Intervention/treatment Phase
Dementia Oral Hygiene Chewing Problem Procedure: Oral Health Procedure: Bite Force Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Oral Health, Bite Force and Dementia - A Randomized Controlled Clinical Trial
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Oral Health - Test Group
- study population is randomly assigned to control and test group
Procedure: Oral Health
  • test group will receive an dental hygiene program for one year
  • control group will remain with dental hygiene regime like done before study participation (maximum of two dental hygiene Treatments per year)

Bite Force/Chewing Efficacy-Test Group
- study population is randomly assigned to control and test group
Procedure: Bite Force
  • test group will receive physiotherapy with the aim of increasing muscle strength in chewing muscles for 3 months
  • control group will remain without such training




Primary Outcome Measures :
  1. Oral Health (dental examination) [ Time Frame: 1 year ]
    Decayed, Missing, Filled - Index (dmf/t)

  2. Chewing function I (examination with force gauge meter) [ Time Frame: 1 year ]
    Bite Force (Bite Force Meter in Newton)


Secondary Outcome Measures :
  1. Nutrition I (questionnaire/ assessment of nutritional state) [ Time Frame: 1 year ]
    Mini Nutritional Assessment (MNA) (Malnutrition present? yes/no/at risk)

  2. Nutrition II (examination for weight and body-size) [ Time Frame: 1 year ]
    Body Mass Index (BMI) (normal weight / under-weight / over-weight)

  3. Chewing function II (two-coloured chewing gum to test efficacy) [ Time Frame: 1 year ]
    Chewing Efficacy (chew two-coloured chewing gum 20 times, visual and optoelectronic evaluation)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • > 59 years
  • no acute processes being present
  • no known cranio-mandibular dysorder (CMD) or finding of any CMD during study participation
  • non or Maximum of one dental hygiene treatment in the last 12 months

Exclusion Criteria:

  • younger than 60 years
  • acute processes in the oral-facial Region
  • known CDM case
  • more than one dental hygiene treatment in the last 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775772


Contacts
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Contact: Julia Kunze, Dr. +41 44 63 43 334 julia.kunze@zzm.uzh.ch

Locations
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Switzerland
Clinic of General, Special Care and Geriatric Dentistry Recruiting
Zürich, Switzerland, 5621
Contact: Julia Kunze, Dr.    +41 44 63 43 334    julia.kunze@zzm.uzh.ch   
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Julia Kunze, Dr. University of Zurich
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03775772    
Other Study ID Numbers: 2017_OrBiD_RCT
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
oral health
bite force
chewing efficiency
dementia
elderly
aged
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders