NCT03775772

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2017

Completed
1.5 years until next milestone

Study Start

First participant enrolled

December 13, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

December 14, 2018

Status Verified

December 1, 2018

Enrollment Period

2.1 years

First QC Date

June 23, 2017

Last Update Submit

December 13, 2018

Conditions

Keywords

oral healthbite forcechewing efficiencydementiaelderlyaged

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Nutrition I (questionnaire/ assessment of nutritional state)

    1 year

  • Nutrition II (examination for weight and body-size)

    1 year

  • Chewing function II (two-coloured chewing gum to test efficacy)

    1 year

Study Arms (2)

Oral Health - Test Group

OTHER

\- study population is randomly assigned to control and test group

Procedure: Oral Health

Bite Force/Chewing Efficacy-Test Group

OTHER

\- study population is randomly assigned to control and test group

Procedure: Bite Force

Interventions

Oral HealthPROCEDURE

* 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)

Oral Health - Test Group
Bite ForcePROCEDURE

* 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

Bite Force/Chewing Efficacy-Test Group

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of General, Special Care and Geriatric Dentistry

Zurich, 5621, Switzerland

RECRUITING

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Dementia

Interventions

Oral HealthBite Force

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

HealthPopulation CharacteristicsDental OcclusionDentistry

Study Officials

  • Julia Kunze, Dr.

    University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2017

First Posted

December 14, 2018

Study Start

December 13, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

December 14, 2018

Record last verified: 2018-12

Locations