<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04401358</url>
  </required_header>
  <id_info>
    <org_study_id>202002115RINC</org_study_id>
    <nct_id>NCT04401358</nct_id>
  </id_info>
  <brief_title>Smell, Taste, Salivary Flow, and Oral Health in Patient Receiving Dialysis: A Before and After Study.</brief_title>
  <official_title>Smell, Taste, Salivary Flow, and Oral Health in Patient Receiving Dialysis: A Before and After Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies show that the change of smell and taste, also dry mouth are the most common symptoms&#xD;
      in end stage renal disease patients, the accumulation of uremic toxins would damage the&#xD;
      intrinsinc antioxidant systems of the olfactory epithelium and olfactory bulb, which leads to&#xD;
      smell dysfunction compared to healthy group. Previous studies show different results about if&#xD;
      getting rid of uremic toxins would help improve smell, even if they say olfactory&#xD;
      identification is improved after hemodialysis episode, but there's no short term reliability&#xD;
      of Sniffin'sticks to prove the credibility of the findings. Reduction of the whole saliva and&#xD;
      unstimulated salivary flow rate cause dry mouth, also change oral environment, which makes&#xD;
      dental plaque easily attach to teeth. And the accumulation of uremic in oral cavity causes&#xD;
      oral odor, plus lack of zinc iron and reduction of saliva would affect the tastants&#xD;
      transferred to its receptors which leads to taste dysfunction. Besides, when the patients has&#xD;
      olfactory dysfunction, the taste will be affected as well, plus the accumulation of uremic&#xD;
      toxin in the oral cavity also stops the conjunction of smell and taste receptors which&#xD;
      affects taste. To understand smell, taste and oral condition in end stage renal disease&#xD;
      patients, and due to there's no short term reliability of Sniffin'sticks, plus it's expensive&#xD;
      and time-consuming to implement the taste assessment tool. Thus the main purpose of this&#xD;
      study is: 1. To investigate smell and taste function, salivary secretion, oral condition,&#xD;
      plaque index and dry mouth in end stage renal disease patients who haven't been under&#xD;
      hemodialysis. 2. To investigate the short term reliability of Sniffin'sticks, the measuring&#xD;
      tool of olfactory with 3-4 hours interval. 3. To investigate if Taste and Smell Survey could&#xD;
      be the tool which detects abnormality of taste 4. To investigate the change of smell, taste&#xD;
      and salivary secretion within 24 hours after the first episode of hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a smell, taste and oral health in patients receiving before and after hemodialysis&#xD;
      study. End stage renal disease patients who haven't been under hemodialysis will be screened&#xD;
      for enrollment at the nephrology department in National Taiwan University Hospital. Patients&#xD;
      have to be over 20 years old who are diagnosed with end stage renal&#xD;
      disease(eGFR&lt;15ml/min/1.73m2) but haven't been under hemodialysis yet. Expected 85 patients&#xD;
      will be enrolled according to power analysis, those who have the diseases such as Parkinson's&#xD;
      disease, hypothyroidism, Sjögren's syndrome, under chemotherapy or radiotherapy, history of&#xD;
      head and neck tumour and surgery, and patients who unable to response to evaluate protocal.&#xD;
&#xD;
      We will first use Montreal Cognitive Assessment to screen patient's cognitive function, for&#xD;
      those scored 23.5 and higher, a full evaluation will be conducted at two points in before&#xD;
      dialysis and afterward. The full evaluation before dialysis include 1.The difference of&#xD;
      smell, taste, salivary secretion, oral assessment guide, plaque index and xerostomia on end&#xD;
      stage renal disease patients before and after hemodialysis. 2.Investigating the reliability&#xD;
      of olfactory identification by using Sniffin'sticks within 2 to 4 hours. 3.Investigating the&#xD;
      correlation between taste questionnaire and taste strips. 4.Salivary flow rate. 5.Oral&#xD;
      Assessment Guide. 6.Plaque Index. 7.Taste threshold sensitivity.&#xD;
&#xD;
      The evaluation after dialysis involved 1.The olfactory identification 2. Salivary flow 3.&#xD;
      Taste threshold sensitivity.For patients who get score lower than 23.5 from Montreal&#xD;
      Cognitive Assessment, we'll skip the test of olfactory and taste .Data will be analyzed with&#xD;
      descriptive and inferential statistics using R studio statistic software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 4, 2020</start_date>
  <completion_date type="Actual">May 5, 2021</completion_date>
  <primary_completion_date type="Actual">May 5, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Olfactory identification score in ESRD patients before the first dialysis</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sniffin' sticks identification retest</measure>
    <time_frame>The test will be done again 2 hours after the first outcome.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of olfactory identification score in ESRD patients after the first dialysis</measure>
    <time_frame>Change of olfactory identification score after the first dialysis. Through study completion, an average of 1 year.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Taste strips in ESRD patients before the first dialysis</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Taste questionnaire</measure>
    <time_frame>Only assessing patient who hasn't received hemodialysis yet. Patient is asked to fill out taste questionnaire, which takes 10 minutes.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Unstimulated Salivary Flow Rate in ESRD patients before the first dialysis</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral Assessment Guide in ESRD patients before the first dialysis</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plaque Index</measure>
    <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.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Xerostomia Inventory</measure>
    <time_frame>Only assessing patient who hasn't received hemodialysis yet. Patient is asked to fill out Xerostomia Inventory, which takes 5 minutes.</time_frame>
    <description>11-items each using 5 points Likert scale are summated to represent the severity of chronic xerostomia; higher scores represent more severe symptoms.</description>
  </primary_outcome>
  <enrollment type="Actual">75</enrollment>
  <condition>ESRD</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are diagnosed with end stage renal disease (eGFR&lt;15ml/min/1.73m2) but haven't&#xD;
        been under hemodialysis yet.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed with end-stage renal disease (eGFR&lt;15ml/min/1.73m2) but haven't been under&#xD;
             hemodialysis yet.&#xD;
&#xD;
          2. Over 20 years old.&#xD;
&#xD;
          3. Able to interact with instructions and communicate with others&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Those who have diseases such as Parkinson's disease, hypothyroidism, Sjögren's syndrome,&#xD;
        under chemotherapy or radiotherapy, head and neck tumor, took head and neck surgery,&#xD;
        unconsciousness, and cognitive dysfunction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10055</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Al-yassiri, A. M. H. (2014). Prevalence of xerostomia in patients with chronic hemodialysis in Babil city. Kerbala Jorunal of Medicine, 7(1), 1822-1828.</citation>
  </reference>
  <reference>
    <citation>Babaee, N., Sales, M., Ghazimirsaeed, A. M., &amp; Moghadamnia, A. A. (2014). Xerostomia in Patients with Chronic Renal Failure Undergoing Hemodialysis. Journal of Babol University of Medical Sciences, 16(10), 15-22.</citation>
  </reference>
  <reference>
    <citation>Bossola M, Tazza L. Xerostomia in patients on chronic hemodialysis. Nat Rev Nephrol. 2012 Jan 17;8(3):176-82. doi: 10.1038/nrneph.2011.218.</citation>
    <PMID>22249779</PMID>
  </reference>
  <reference>
    <citation>Chen A, Wai Y, Lee L, Lake S, Woo SB. Using the modified Schirmer test to measure mouth dryness: a preliminary study. J Am Dent Assoc. 2005 Feb;136(2):164-70; quiz 229-30. doi: 10.14219/jada.archive.2005.0137.</citation>
    <PMID>15782519</PMID>
  </reference>
  <reference>
    <citation>Delli K, Spijkervet FK, Kroese FG, Bootsma H, Vissink A. Xerostomia. Monogr Oral Sci. 2014;24:109-25. doi: 10.1159/000358792. Epub 2014 May 23.</citation>
    <PMID>24862599</PMID>
  </reference>
  <reference>
    <citation>Edgar, W. M., O'Mullane, D. M., &amp; Dawes, C. (Eds.). (2004). Saliva and oral health (Vol. 146). London: British Dental Association.</citation>
  </reference>
  <reference>
    <citation>Eilers J, Berger AM, Petersen MC. Development, testing, and application of the oral assessment guide. Oncol Nurs Forum. 1988 May-Jun;15(3):325-30. No abstract available.</citation>
    <PMID>3287344</PMID>
  </reference>
  <reference>
    <citation>Escobar, A., &amp; Aitken-Saavedra, J. P. (2018). Xerostomia: An Update of Causes and Treatments. In Salivary Glands-New Approaches in Diagnostics and Treatment. IntechOpen.</citation>
  </reference>
  <reference>
    <citation>Fan WF, Zhang Q, Luo LH, Niu JY, Gu Y. Study on the clinical significance and related factors of thirst and xerostomia in maintenance hemodialysis patients. Kidney Blood Press Res. 2013;37(4-5):464-74. doi: 10.1159/000355717. Epub 2013 Oct 22.</citation>
    <PMID>24247643</PMID>
  </reference>
  <reference>
    <citation>Kidney Disease: Improving Global Outcomes (KDIGO) Hepatitis C Work Group. KDIGO 2018 Clinical Practice Guideline for the Prevention, Diagnosis, Evaluation, and Treatment of Hepatitis C in Chronic Kidney Disease. Kidney Int Suppl (2011). 2018 Oct;8(3):91-165. doi: 10.1016/j.kisu.2018.06.001. Epub 2018 Sep 19. No abstract available.</citation>
    <PMID>30675443</PMID>
  </reference>
  <reference>
    <citation>Konstantinova, D., Nenova-Nogalcheva, A., Pechalova, P., Pancheva, R., &amp; Andonova, D. (2017). Xerostomia as a Contributing Factor for Taste Distortion in Patients Undergoing Chronic Dialysis Treatment. American Research Journal of Dentistry, 1, 6.</citation>
  </reference>
  <reference>
    <citation>Lopez-Jornet P, Bermejo-Fenoll A, Bagan-Sebastian JV, Pascual-Gomez E. Comparison of a new test for the measurement of resting whole saliva with the draining and the swab techniques. Braz Dent J. 1996;7(2):81-6.</citation>
    <PMID>9206358</PMID>
  </reference>
  <reference>
    <citation>Manley KJ. Saliva composition and upper gastrointestinal symptoms in chronic kidney disease. J Ren Care. 2014 Sep;40(3):172-9. doi: 10.1111/jorc.12062. Epub 2014 Mar 20.</citation>
    <PMID>24650153</PMID>
  </reference>
  <reference>
    <citation>Mercadante V, Al Hamad A, Lodi G, Porter S, Fedele S. Interventions for the management of radiotherapy-induced xerostomia and hyposalivation: A systematic review and meta-analysis. Oral Oncol. 2017 Mar;66:64-74. doi: 10.1016/j.oraloncology.2016.12.031. Epub 2017 Jan 19.</citation>
    <PMID>28249650</PMID>
  </reference>
  <reference>
    <citation>Mortazavi H, Baharvand M, Movahhedian A, Mohammadi M, Khodadoustan A. Xerostomia due to systemic disease: a review of 20 conditions and mechanisms. Ann Med Health Sci Res. 2014 Jul;4(4):503-10. doi: 10.4103/2141-9248.139284.</citation>
    <PMID>25221694</PMID>
  </reference>
  <reference>
    <citation>Proctor GB. The physiology of salivary secretion. Periodontol 2000. 2016 Feb;70(1):11-25. doi: 10.1111/prd.12116.</citation>
    <PMID>26662479</PMID>
  </reference>
  <reference>
    <citation>Punj &amp; Anahita. (2019). Secretions of Human Salivary Gland. In Salivary Glands - New Approaches in Diagnostics and Treatment.</citation>
  </reference>
  <reference>
    <citation>Ristevska, I., Armata, R. S., D'Ambrosio, C., Furtado, M., Anand, L., &amp; Katzman, M. A. (2015). Xerostomia: understanding the diagnosis and the treatment of dry mouth. J Fam Med Dis Prev, 1(2), 1-5.</citation>
  </reference>
  <reference>
    <citation>Ruospo M, Palmer SC, Craig JC, Gentile G, Johnson DW, Ford PJ, Tonelli M, Petruzzi M, De Benedittis M, Strippoli GF. Prevalence and severity of oral disease in adults with chronic kidney disease: a systematic review of observational studies. Nephrol Dial Transplant. 2014 Feb;29(2):364-75. doi: 10.1093/ndt/gft401. Epub 2013 Sep 29.</citation>
    <PMID>24081863</PMID>
  </reference>
  <reference>
    <citation>Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.</citation>
    <PMID>5264376</PMID>
  </reference>
  <reference>
    <citation>Thomson WM, Chalmers JM, Spencer AJ, Williams SM. The Xerostomia Inventory: a multi-item approach to measuring dry mouth. Community Dent Health. 1999 Mar;16(1):12-7.</citation>
    <PMID>10697349</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>April 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>August 21, 2022</last_update_submitted>
  <last_update_submitted_qc>August 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ESRD</keyword>
  <keyword>Renal Dialysis</keyword>
  <keyword>olfaction</keyword>
  <keyword>Sniffin' sticks</keyword>
  <keyword>MoCA</keyword>
  <keyword>taste</keyword>
  <keyword>Taste strips</keyword>
  <keyword>modified Schirmer's test</keyword>
  <keyword>OAG</keyword>
  <keyword>Plaque Index</keyword>
  <keyword>Xerostomia Inventory</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04401358
org study id: 202002115RINC
nct id: NCT04401358
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Prospective
measure: Olfactory identification score in ESRD patients before the first dialysis
time frame: Through study completion, an average of 1 year.
description: 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.
measure: Sniffin' sticks identification retest
time frame: The test will be done again 2 hours after the first outcome.
description: 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.
measure: 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.
description: 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.
measure: Taste strips in ESRD patients before the first dialysis
time frame: Through study completion, an average of 1 year.
description: 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.
measure: 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.
description: 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.
measure: Unstimulated Salivary Flow Rate in ESRD patients before the first dialysis
time frame: Through study completion, an average of 1 year.
description: 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)
measure: Oral Assessment Guide in ESRD patients before the first dialysis
time frame: Through study completion, an average of 1 year.
description: 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.
measure: 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.
description: 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.
measure: 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.
description: 11-items each using 5 points Likert scale are summated to represent the severity of chronic xerostomia; higher scores represent more severe symptoms.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
facility: 
country: Taiwan
citation: Al-yassiri, A. M. H. (2014). Prevalence of xerostomia in patients with chronic hemodialysis in Babil city. Kerbala Jorunal of Medicine, 7(1), 1822-1828.
citation: Babaee, N., Sales, M., Ghazimirsaeed, A. M., & Moghadamnia, A. A. (2014). Xerostomia in Patients with Chronic Renal Failure Undergoing Hemodialysis. Journal of Babol University of Medical Sciences, 16(10), 15-22.
citation: Bossola M, Tazza L. Xerostomia in patients on chronic hemodialysis. Nat Rev Nephrol. 2012 Jan 17;8(3):176-82. doi: 10.1038/nrneph.2011.218.
PMID: 22249779
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