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Smell, Taste, Salivary Flow, and Oral Health in Patient Receiving Dialysis: A Before and After Study.

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ClinicalTrials.gov Identifier: NCT04401358
Recruitment Status : Enrolling by invitation
First Posted : May 26, 2020
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date April 13, 2020
First Posted Date May 26, 2020
Last Update Posted Date May 26, 2020
Actual Study Start Date May 4, 2020
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2020)
  • Olfactory identification score in ESRD patients before the first dialysis [ Time Frame: Through study completion, an average of 1 year. ]
    The Sniffin' sticks identification test measured the patient's olfactory identification . The test consists of felt pens, the tips of which are impregnated with 4 mL of odorant fluid or odorant substance dissolved in propylene glycol, and an antibacterial agent. There were 16 odorant pens in the test, for each odorant pen, the subject must make a forced choice from a list of 4 written proposals. The test scored from 1 to 16, normosmia to be defined as a score higher than the 10th percentile of the distribution of normal values of the study population according to gender and age.
  • Sniffin' sticks identification retest [ Time Frame: The test will be done again 2 hours after the first outcome. ]
    Though the sniffin'sticks test provided good reliability, but the time interval is 7-10 days, the short term of reliability hadn't been confirmed, hence we want to test a short term interval within 2 hours. The test will be done again 2 hours after the first outcome.
  • The change of olfactory identification score in ESRD patients after the first dialysis [ Time Frame: Change of olfactory identification score after the first dialysis. Through study completion, an average of 1 year. ]
    The Sniffin' sticks identification test measured the patient's olfactory identification. The test consists of felt pens, the tips of which are impregnated with 4 mL of odorant fluid or odorant substance dissolved in propylene glycol, and an antibacterial agent. There were 16 odorant pens in the test, for each odorant pen, the subject must make a forced choice from a list of 4 written proposals. The test scored from 1 to 16, normosmia to be defined as a score higher than the 10th percentile of the distribution of normal values of the study population according to gender and age.
  • Taste strips in ESRD patients before the first dialysis [ Time Frame: Through study completion, an average of 1 year. ]
    There are total 16 items, each has one point scale to access taste abnormality. The total score is from 0 to 16, when below 12 will be considered as taste abnormality.
  • Taste questionnaire [ Time Frame: Only assessing patient who hasn't received hemodialysis yet. Patient is asked to fill out taste questionnaire, which takes 10 minutes. ]
    There are total 9 items, among eight items have one point scale and one item has one sclae point. The questionnaire total score is from 0 to 10, for evaluate the subjective taste function and compared to taste strip score.
  • Unstimulated Salivary Flow Rate in ESRD patients before the first dialysis [ Time Frame: Through study completion, an average of 1 year. ]
    Patient is asked to spit out all the saliva and to sit in semi-fowler's position, Whatman 41 test strip is then placed under patient's tongue. Read the result after 3 minutes. (the unit is mm/min)
  • Oral Assessment Guide in ESRD patients before the first dialysis [ Time Frame: Through study completion, an average of 1 year. ]
    There are 8 items in this guide, each has a 3 points scale to assess oral health condition and oral function, which includes: voice, swallowing, lips, tongue, saliva, buccal mucous membrane, labial mucous membrane, and gingiva. One point means normal, two means mild change, while three means moderate to severe change. The higher of the total score, the more serious of oral mucositis.
  • Plaque Index [ Time Frame: 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. ]
    First, applying vaseline onto patient's lips to avoid their lips being dyed by the plaque disclosing agent, then applying plaque disclosing solution onto both facial and lingual surfaces of patient's teeth, later asking patient to gargle for 30 seconds. All teeth assessed except third molars, score form 0 to 5 is given according to the scoring criteria, and each side of tooth gets a score, the total score divides the number of surfaces examined is the index. An index of 0 or 1 is considered low while of 2 or more is considered high.
  • Xerostomia Inventory [ Time Frame: Only assessing patient who hasn't received hemodialysis yet. Patient is asked to fill out Xerostomia Inventory, which takes 5 minutes. ]
    11-items each using 5 points Likert scale are summated to represent the severity of chronic xerostomia; higher scores represent more severe symptoms.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Smell, Taste, Salivary Flow, and Oral Health in Patient Receiving Dialysis: A Before and After Study.
Official Title Smell, Taste, Salivary Flow, and Oral Health in Patient Receiving Dialysis: A Before and After Study
Brief Summary Studies show that the change of smell and taste, also dry mouth are the most common symptoms in end stage renal disease patients, the accumulation of uremic toxins would damage the intrinsinc antioxidant systems of the olfactory epithelium and olfactory bulb, which leads to smell dysfunction compared to healthy group. Previous studies show different results about if getting rid of uremic toxins would help improve smell, even if they say olfactory identification is improved after hemodialysis episode, but there's no short term reliability of Sniffin'sticks to prove the credibility of the findings. Reduction of the whole saliva and unstimulated salivary flow rate cause dry mouth, also change oral environment, which makes dental plaque easily attach to teeth. And the accumulation of uremic in oral cavity causes oral odor, plus lack of zinc iron and reduction of saliva would affect the tastants transferred to its receptors which leads to taste dysfunction. Besides, when the patients has olfactory dysfunction, the taste will be affected as well, plus the accumulation of uremic toxin in the oral cavity also stops the conjunction of smell and taste receptors which affects taste. To understand smell, taste and oral condition in end stage renal disease patients, and due to there's no short term reliability of Sniffin'sticks, plus it's expensive and time-consuming to implement the taste assessment tool. Thus the main purpose of this study is: 1. To investigate smell and taste function, salivary secretion, oral condition, plaque index and dry mouth in end stage renal disease patients who haven't been under hemodialysis. 2. To investigate the short term reliability of Sniffin'sticks, the measuring tool of olfactory with 3-4 hours interval. 3. To investigate if Taste and Smell Survey could be the tool which detects abnormality of taste 4. To investigate the change of smell, taste and salivary secretion within 24 hours after the first episode of hemodialysis.
Detailed 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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who are diagnosed with end stage renal disease (eGFR<15ml/min/1.73m2) but haven't been under hemodialysis yet.
Condition ESRD
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 20, 2020)
85
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04401358
Other Study ID Numbers 202002115RINC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account National Taiwan University Hospital
Verification Date April 2020