Oral Health, Bite Force and Dementia

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

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

Conditions
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Dementia, Oral Hygiene, Chewing Problem

Intervention / Treatment
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* Procedure: Oral Health
* Procedure: Bite Force


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oral Health - Test Group<br>- study population is randomly assigned to control and test group | Procedure: Oral Health<br>* 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)<br>|
| Other: Bite Force/Chewing Efficacy-Test Group<br>- study population is randomly assigned to control and test group | Procedure: Bite Force<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Health (dental examination) | Decayed, Missing, Filled - Index (dmf/t) | 1 year | 
| Chewing function I (examination with force gauge meter) | 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) | Mini Nutritional Assessment (MNA) (Malnutrition present? yes/no/at risk) | 1 year | 
| Nutrition II (examination for weight and body-size) | Body Mass Index (BMI) (normal weight / under-weight / over-weight) | 1 year | 
| Chewing function II (two-coloured chewing gum to test efficacy) | Chewing Efficacy (chew two-coloured chewing gum 20 times, visual and optoelectronic evaluation) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral health, bite force, chewing efficiency, dementia, elderly, aged