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Oral Health, Bite Force and Dementia (OrBiD)

Primary Purpose

Dementia, Oral Hygiene, Chewing Problem

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Oral Health
Bite Force
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dementia focused on measuring oral health, bite force, chewing efficiency, dementia, elderly, aged

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinic of General, Special Care and Geriatric DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Oral Health - Test Group

Bite Force/Chewing Efficacy-Test Group

Arm Description

- study population is randomly assigned to control and test group

- study population is randomly assigned to control and test group

Outcomes

Primary Outcome Measures

Oral Health (dental examination)
Decayed, Missing, Filled - Index (dmf/t)
Chewing function I (examination with force gauge meter)
Bite Force (Bite Force Meter in Newton)

Secondary Outcome Measures

Nutrition I (questionnaire/ assessment of nutritional state)
Mini Nutritional Assessment (MNA) (Malnutrition present? yes/no/at risk)
Nutrition II (examination for weight and body-size)
Body Mass Index (BMI) (normal weight / under-weight / over-weight)
Chewing function II (two-coloured chewing gum to test efficacy)
Chewing Efficacy (chew two-coloured chewing gum 20 times, visual and optoelectronic evaluation)

Full Information

First Posted
June 23, 2017
Last Updated
December 13, 2018
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03775772
Brief Title
Oral Health, Bite Force and Dementia
Acronym
OrBiD
Official Title
Oral Health, Bite Force and Dementia - A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 13, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Oral Hygiene, Chewing Problem
Keywords
oral health, bite force, chewing efficiency, dementia, elderly, aged

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Health - Test Group
Arm Type
Other
Arm Description
- study population is randomly assigned to control and test group
Arm Title
Bite Force/Chewing Efficacy-Test Group
Arm Type
Other
Arm Description
- study population is randomly assigned to control and test group
Intervention Type
Procedure
Intervention Name(s)
Oral Health
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Bite Force
Intervention Description
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 Measure Information:
Title
Oral Health (dental examination)
Description
Decayed, Missing, Filled - Index (dmf/t)
Time Frame
1 year
Title
Chewing function I (examination with force gauge meter)
Description
Bite Force (Bite Force Meter in Newton)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Nutrition I (questionnaire/ assessment of nutritional state)
Description
Mini Nutritional Assessment (MNA) (Malnutrition present? yes/no/at risk)
Time Frame
1 year
Title
Nutrition II (examination for weight and body-size)
Description
Body Mass Index (BMI) (normal weight / under-weight / over-weight)
Time Frame
1 year
Title
Chewing function II (two-coloured chewing gum to test efficacy)
Description
Chewing Efficacy (chew two-coloured chewing gum 20 times, visual and optoelectronic evaluation)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Kunze, Dr.
Phone
+41 44 63 43 334
Email
julia.kunze@zzm.uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Kunze, Dr.
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of General, Special Care and Geriatric Dentistry
City
Zürich
ZIP/Postal Code
5621
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Kunze, Dr.
Phone
+41 44 63 43 334
Email
julia.kunze@zzm.uzh.ch

12. IPD Sharing Statement

Citations:
PubMed Identifier
36153477
Citation
Jockusch J, Hahnel S, Nitschke I. Use of handgrip strength measurement as an alternative for assessing chewing function in people with dementia. BMC Geriatr. 2022 Sep 24;22(1):769. doi: 10.1186/s12877-022-03452-2.
Results Reference
derived
PubMed Identifier
34391408
Citation
Jockusch J, Hopfenmuller W, Nitschke I. Influence of cognitive impairment and dementia on oral health and the utilization of dental services : Findings of the Oral Health, Bite force and Dementia Study (OrBiD). BMC Oral Health. 2021 Aug 14;21(1):399. doi: 10.1186/s12903-021-01753-3.
Results Reference
derived

Learn more about this trial

Oral Health, Bite Force and Dementia

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