Oral Health, Bite Force and Dementia (OrBiD)

December 13, 2018 updated by: University of Zurich

Oral Health, Bite Force and Dementia - A Randomized Controlled Clinical Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 5621
        • Recruiting
        • Clinic of General, Special Care and Geriatric Dentistry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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)
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Health (dental examination)
Time Frame: 1 year
Decayed, Missing, Filled - Index (dmf/t)
1 year
Chewing function I (examination with force gauge meter)
Time Frame: 1 year
Bite Force (Bite Force Meter in Newton)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrition I (questionnaire/ assessment of nutritional state)
Time Frame: 1 year
Mini Nutritional Assessment (MNA) (Malnutrition present? yes/no/at risk)
1 year
Nutrition II (examination for weight and body-size)
Time Frame: 1 year
Body Mass Index (BMI) (normal weight / under-weight / over-weight)
1 year
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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Julia Kunze, Dr., University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

June 23, 2017

First Submitted That Met QC Criteria

December 13, 2018

First Posted (Actual)

December 14, 2018

Study Record Updates

Last Update Posted (Actual)

December 14, 2018

Last Update Submitted That Met QC Criteria

December 13, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017_OrBiD_RCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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