Oral health and oral health-related quality of life in pa-tients with peripheral facial nerve palsy - a case-control-study

• Register: German Clinical Trials Register
• Last refreshed on: 21 June 2021
• Main ID: DRKS00025358
• Date of registration: 20/05/2021
• Prospective Registration: No
• Primary sponsor: Universitätsklinikum Jena
• Public title: Oral health and oral health-related quality of life in pa-tients with peripheral facial nerve palsy - a case-control-study
• Scientific title: Oral health and oral health-related quality of life in pa-tients with peripheral facial nerve palsy - a case-control-study - Oral health and facial nerve palsy
• Date of first enrolment: 01/09/2020
• Target sample size: 100
• Recruitment status: Complete: follow-up complete
• URL: http://www.drks.de/DRKS00025358
• Study type: observational
• Study design: Allocation: Non-randomized controlled trial;. Masking: Open (masking not used). Control: Control group receives no treatment. Assignment: Parallel. Study design purpose: Prevention;

Countries of recruitment

Germany

Contacts

• Name: Lisa Strobelt
• Affiliation: Universitätsklinikum Jena Zentrum für Zahn-, Mund- und Kieferheilkunde

• Name: Lisa Strobelt
• Affiliation: Universitätsklinikum Jena Zentrum für Zahn-, Mund- und Kieferheilkunde

Key inclusion & exclusion criteria

Inclusion criteria: Patients: peripheral facial nerve palsy (diagnosed by a doctor); voluntary consent
Control subjects: no facial nerve palsy ever diagnosed by a doctor; matchable with patients by age and sex; voluntary consent
Exclusion criteria: multimorbid people; people with diabetes mellitus type 1 and 2; people with hemophilia A and B; people with epilepsy or AIDS; toothless people; lack of study consent

Age minimum: 18 Years
Age maximum: no maximum age
Gender: Both, male and female

Health Condition(s) or Problem(s) studied

G51.0 - Bell palsy

Intervention(s)

Intervention 1: Patients with peripheral facial nerve palsy received a one-time dental check-up and were interviewed once using the following questionnaires: Edinburgh Handyness Inventory, OHIP-G14 questionnaire, questionnaire for subjective assessment of own oral hygiene, further data extraction from FDI and FaCE questionnaires of the ENT Clinic Jena, the examination was carried out after submission to the Ethics Committee Jena according to its guidelines. Intervention 2: Control subjects without facial paresis ever diagnosed by a doctor received a one-time dental check-up and were interviewed once using the following questionnaires: Edinburgh Handyness Inventory, OHIP-G14 questionnaire, questionnaire on subjective assessment of own oral hygiene, the interview was carried out after submission to the Jena Ethics Committee according to its guidelines.

Primary Outcome(s)

The primary objectives of the study are to assess the oral health of patients with facial nerve palsy in comparison to an age- and gender-matched control group and to analyse factors influencing oral health.
The dental examination of various oral indices (API, BNS,..) by a calibrated dentist took place up to and including October 2020.

Secondary Outcome(s)

The secondary objective of the study is to analyse the psycho-emotional effects of oral health on quality of life.
The study participants were interviewed using the Edinburgh Handyness Inventory questionnaire, the OHIP-G14 questionnaire and a questionnaire on the subjective assessment of their own oral hygiene up to and including October 2020.

Secondary ID(s)

2020-1883-BO

Source(s) of Monetary Support

Universitätsklinikum Jena

Ethics review

Status: approved
Approval date: 28/08/2020
Contact:

Results

• Date Completed: 15/10/2020