The Change of the Structure and Function of Taste Buds After the Otosclerosis Surgery

NCT04881513 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-09-30

No results posted yet for this study

Summary

Patients admitted for the otosclerosis operation are included in the study. The Narrow Band Imaging (NBI) of their taste buds is performed before the operation. The sensory function of the anterior 2/3 of the tongue is tested with the two point discrimination discs, the taste is tested with taste strips and the SF-36 questionnaire is applied. During the operation in local anesthesia the threshold for the tongue sensation (by the stimulation of the chorda tympani nerve) of the first 2/3 of the tongue at the beginning of the operation (when we first encounter the chorda tympani nerve) and at the end of the operation is measured.One month and six months after the operation the tests are being repeated (NBI, two-point discrimination and SF-36 questionnaire).

The study has the National Ethical Committee approval.

Conditions

  • Chorda Tympani Disorder
  • Taste Disorders
  • Stapes Fixation

Interventions

DIAGNOSTIC_TEST

Narrow Band Imaging

Testing the taste buds structure (blood vessels morphology- classified to 5 types) and the number of taste buds per 20mm2, by Narrow Band Imaging technique before and after the operation (one and six months)

DIAGNOSTIC_TEST

Tongue sensitivity testing

testing the tongue sensitivity change prior to surgery and after (1 and 6 months) the surgery with two point discrimination test in mm.

OTHER

Qualitiy of life

Testing the patients quality of life before and after (one and six months) the stapes surgery by SF 36 questionnaire

DIAGNOSTIC_TEST

Threshold change

Measuring the intraoperative chorda tympani stimulation threshold change at the beginning and at the end of the procedure- surgery

DIAGNOSTIC_TEST

Taste

Taste is measured by applying taste strips (sweet, sour, salty, bitter) in 4 concentrations prior to, 1 and 6 months after surgery.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Nina Božanić Urbančič, MD · UMC Ljubljana

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-12-30
Completion
2022-01-01

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04881513 on ClinicalTrials.gov