Smell, Taste, Salivary Flow, and Oral Health in Patient Receiving Dialysis: A Before and After Study.
Keywords
Abstract
Description
This is a smell, taste and oral health in patients receiving before and after hemodialysis study. End stage renal disease patients who haven't been under hemodialysis will be screened for enrollment at the nephrology department in National Taiwan University Hospital. Patients have to be over 20 years old who are diagnosed with end stage renal disease(eGFR<15ml/min/1.73m2) but haven't been under hemodialysis yet. Expected 85 patients will be enrolled according to power analysis, those who have the diseases such as Parkinson's disease, hypothyroidism, Sjögren's syndrome, under chemotherapy or radiotherapy, history of head and neck tumour and surgery, and patients who unable to response to evaluate protocal.
We will first use Montreal Cognitive Assessment to screen patient's cognitive function, for those scored 23.5 and higher, a full evaluation will be conducted at two points in before dialysis and afterward. The full evaluation before dialysis include 1.The difference of smell, taste, salivary secretion, oral assessment guide, plaque index and xerostomia on end stage renal disease patients before and after hemodialysis. 2.Investigating the reliability of olfactory identification by using Sniffin'sticks within 2 to 4 hours. 3.Investigating the correlation between taste questionnaire and taste strips. 4.Salivary flow rate. 5.Oral Assessment Guide. 6.Plaque Index. 7.Taste threshold sensitivity.
The evaluation after dialysis involved 1.The olfactory identification 2. Salivary flow 3. Taste threshold sensitivity.For patients who get score lower than 23.5 from Montreal Cognitive Assessment, we'll skip the test of olfactory and taste .Data will be analyzed with descriptive and inferential statistics using R studio statistic software.
Dates
Last Verified: | 03/31/2020 |
First Submitted: | 04/12/2020 |
Estimated Enrollment Submitted: | 05/19/2020 |
First Posted: | 05/25/2020 |
Last Update Submitted: | 05/19/2020 |
Last Update Posted: | 05/25/2020 |
Actual Study Start Date: | 05/03/2020 |
Estimated Primary Completion Date: | 03/31/2021 |
Estimated Study Completion Date: | 03/31/2021 |
Condition or disease
Phase
Eligibility Criteria
Ages Eligible for Study | 20 Years To 20 Years |
Sexes Eligible for Study | All |
Sampling method | Non-Probability Sample |
Accepts Healthy Volunteers | No |
Criteria | Inclusion Criteria: 1. Diagnosed with end-stage renal disease (eGFR<15ml/min/1.73m2) but haven't been under hemodialysis yet. 2. Over 20 years old. 3. Able to interact with instructions and communicate with others Exclusion Criteria: 1. Those who have diseases such as Parkinson's disease, hypothyroidism, Sjögren's syndrome, under chemotherapy or radiotherapy, head and neck tumor, took head and neck surgery, unconsciousness, and cognitive dysfunction. |
Outcome
Primary Outcome Measures
1. Olfactory identification score in ESRD patients before the first dialysis [Through study completion, an average of 1 year.]
2. Sniffin' sticks identification retest [The test will be done again 2 hours after the first outcome.]
3. The change of olfactory identification score in ESRD patients after the first dialysis [Change of olfactory identification score after the first dialysis. Through study completion, an average of 1 year.]
4. Taste strips in ESRD patients before the first dialysis [Through study completion, an average of 1 year.]
5. Taste questionnaire [Only assessing patient who hasn't received hemodialysis yet. Patient is asked to fill out taste questionnaire, which takes 10 minutes.]
6. Unstimulated Salivary Flow Rate in ESRD patients before the first dialysis [Through study completion, an average of 1 year.]
7. Oral Assessment Guide in ESRD patients before the first dialysis [Through study completion, an average of 1 year.]
8. Plaque Index [Only assessing patient who hasn't received hemodialysis yet. When Oral Assessment Guide is done, using plaque disclosing agent along with the scoring criteria to evaluate patient's plaque index, which takes 15 minutes.]
9. Xerostomia Inventory [Only assessing patient who hasn't received hemodialysis yet. Patient is asked to fill out Xerostomia Inventory, which takes 5 minutes.]