Prevalence of Oral Findings in Chronic Kidney Disease

Overview

There are severe deficiency of database concerning the oral health status in both pre-dialysis and end stage renal disease in Egyptian population. Our aim in the present study is to assess the oral health of the chronic kidney disease patients to increase their awareness and minimize all the possible risk factors, to achieve a proper management for all oral problems.

Full Title of Study: “Prevalence of Oral Findings in Adult Patients With Chronic Kidney Disease “Cross Sectional”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: May 30, 2018

Detailed Description

The study will be held in the Nephrology units at the Kasr Al-Ainy Cairo university hospital. The data collected through the questionnaire will be obtained through an interview between the investigator and the patient. Clinical examination will be performed for both oral (soft tissue) and dental (hard) tissue. For patients undergoing dialysis, examination will be performed before dialysis therapy. Selection bias: will be minimized by enrolling the participants in the study in a consecutive order of the entering the clinic. Non-respondent bias: will be minimized by explaining to the participants the aim of the study and their importance and role in the study. Incomplete records: will be excluded from statistical analysis with reporting the cause of not completing the record. Sample size estimation: Using a precision of 5, a design effect set at 1 with 90% CI (confidence interval), a total sample size of 250 pre-dialysis patients and 200 end stage renal disease patients will be sufficient. The sample size was calculated by Epi info software. The sample will be divided between two researchers; each researcher will have 50% of the whole sample to collect.

Arms, Groups and Cohorts

  • pre-dialysis patients
  • end stage renal disease

Clinical Trial Outcome Measures

Primary Measures

  • oral mucosal lesion
    • Time Frame: 10 minutes
    • Clinical examination according to WHO guidelines

Secondary Measures

  • .Periodontal condition
    • Time Frame: 10 minutes
    • Basic periodontal examination
  • Hepatitis C Virus at dialysis stage
    • Time Frame: 5 minutes
    • HCV antibodies in patient blood

Participating in This Clinical Trial

Inclusion Criteria

1. Adult patients >18 years old with a diagnosis of non-dialysis chronic kidney disease at stage 2, 3 and 4. 2. Adult patients >18 years old with a diagnosis of end stage renal disease "stage 5". 3. Recorded data of Glomerular Filtration Rate for every patient. 4. Recorded data for dialysis patients (HCV, platelets count, creatinine, blood urea nitrogen, urea level and partial thromboplastin time). Exclusion Criteria:

1. Adult patients <18 years. 2. End stage renal disease undergoing peritoneal dialysis. 3. Patients not physically able to participate in oral examination. 4. Patients with kidney transplantation. 5. Patients undergoing renal dialysis for reasons other than chronic kidney disease, such as acute renal failure, accidents, trauma, snake poisoning.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Alaa Mostafa Hassan Elnaggar
  • Collaborator
    • Cairo University
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Alaa Mostafa Hassan Elnaggar, internal resident at oral medicine department – Cairo University
  • Overall Official(s)
    • Mariam fakhr, Study Chair, the Nephrology units at the Kasr Al-Ainy Cairo university hospital.
  • Overall Contact(s)
    • alaa elnaggar, BDS, 01007802767, alaa_hassan@dentistry.cu.edu.eg

Citations Reporting on Results

Gautam NR, Gautam NS, Rao TH, Koganti R, Agarwal R, Alamanda M. Effect of end-stage renal disease on oral health in patients undergoing renal dialysis: A cross-sectional study. J Int Soc Prev Community Dent. 2014 Sep;4(3):164-9. doi: 10.4103/2231-0762.142006.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.