Oral Health, Bite Force and Dementia

Dementia Clinical Trial

— OrBiD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03775772
• Other study ID #: 2017_OrBiD_RCT
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2018
• Source: University of Zurich
• Contact: Julia Kunze, Dr.
• Phone: +41 44 63 43 334
• Email: julia.kunze[@]zzm.uzh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chewing Problem
• Dementia
• Oral Hygiene

Intervention

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
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

Locations

Country	Name	City	State
Switzerland	Clinic of General, Special Care and Geriatric Dentistry	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Health (dental examination)	Decayed, Missing, Filled - Index (dmf/t)	1 year
Primary	Chewing function I (examination with force gauge meter)	Bite Force (Bite Force Meter in Newton)	1 year
Secondary	Nutrition I (questionnaire/ assessment of nutritional state)	Mini Nutritional Assessment (MNA) (Malnutrition present? yes/no/at risk)	1 year
Secondary	Nutrition II (examination for weight and body-size)	Body Mass Index (BMI) (normal weight / under-weight / over-weight)	1 year
Secondary	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