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

NCT04401358 | Completed

• 1 other identifier: 202002115RINC
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

ESRD

Keywords

ESRD; Renal Dialysis; olfaction; Sniffin' sticks; MoCA; taste; Taste strips; modified Schirmer's test; OAG; Plaque Index; Xerostomia Inventory

Outcome Measures

Primary Outcomes (9)

• Olfactory identification score in ESRD patients before the first dialysis

  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.

  Through study completion, an average of 1 year.

• Sniffin' sticks identification retest

  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 test will be done again 2 hours after the first outcome.

• The change of olfactory identification score in ESRD patients after the first dialysis

  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.

  Change of olfactory identification score after the first dialysis. Through study completion, an average of 1 year.

• Taste strips in ESRD patients before the first dialysis

  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.

  Through study completion, an average of 1 year.

• Taste questionnaire

  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.

  Only assessing patient who hasn't received hemodialysis yet. Patient is asked to fill out taste questionnaire, which takes 10 minutes.

• Unstimulated Salivary Flow Rate in ESRD patients before the first dialysis

  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)

  Through study completion, an average of 1 year.

• Oral Assessment Guide in ESRD patients before the first dialysis

  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.

  Through study completion, an average of 1 year.

• Plaque Index

  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.

  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.

• Xerostomia Inventory

  11-items each using 5 points Likert scale are summated to represent the severity of chronic xerostomia; higher scores represent more severe symptoms.

  Only assessing patient who hasn't received hemodialysis yet. Patient is asked to fill out Xerostomia Inventory, which takes 5 minutes.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosed with end-stage renal disease (eGFR\<15ml/min/1.73m2) but haven't been under hemodialysis yet.
• Over 20 years old.
• Able to interact with instructions and communicate with others

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10055, Taiwan

Location

Related Publications (21)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 15782519 BACKGROUND

• 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.

  PMID: 24862599 BACKGROUND

• Edgar, W. M., O'Mullane, D. M., & Dawes, C. (Eds.). (2004). Saliva and oral health (Vol. 146). London: British Dental Association.

  BACKGROUND

• 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.

  PMID: 3287344 BACKGROUND

• Escobar, A., & Aitken-Saavedra, J. P. (2018). Xerostomia: An Update of Causes and Treatments. In Salivary Glands-New Approaches in Diagnostics and Treatment. IntechOpen.

  BACKGROUND

• 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.

  PMID: 24247643 BACKGROUND

• 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.

  PMID: 30675443 BACKGROUND

• Konstantinova, D., Nenova-Nogalcheva, A., Pechalova, P., Pancheva, R., & Andonova, D. (2017). Xerostomia as a Contributing Factor for Taste Distortion in Patients Undergoing Chronic Dialysis Treatment. American Research Journal of Dentistry, 1, 6.

  BACKGROUND

• 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.

  PMID: 9206358 BACKGROUND

• 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.

  PMID: 24650153 BACKGROUND

• 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.

  PMID: 28249650 BACKGROUND

• 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.

  PMID: 25221694 BACKGROUND

• Proctor GB. The physiology of salivary secretion. Periodontol 2000. 2016 Feb;70(1):11-25. doi: 10.1111/prd.12116.

  PMID: 26662479 BACKGROUND

• Punj & Anahita. (2019). Secretions of Human Salivary Gland. In Salivary Glands - New Approaches in Diagnostics and Treatment.

  BACKGROUND

• Ristevska, I., Armata, R. S., D'Ambrosio, C., Furtado, M., Anand, L., & Katzman, M. A. (2015). Xerostomia: understanding the diagnosis and the treatment of dry mouth. J Fam Med Dis Prev, 1(2), 1-5.

  BACKGROUND

• 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.

  PMID: 24081863 BACKGROUND

• 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.

  PMID: 5264376 BACKGROUND

• 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.

  PMID: 10697349 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Anosmia

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: May 26, 2020
• Study Start: May 4, 2020
• Primary Completion: May 5, 2021
• Study Completion: May 5, 2021
• Last Updated: August 23, 2022

Record last verified: 2021-10

Locations

TW (1)