Clinical Trial: Prevalence of Oral Findings in Chronic Kidney Disease

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational [Patient Registry]

Official Title: Prevalence of Oral Findings in Adult Patients With Chronic Kidney Disease "Cross Sectional

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Alaa Mostafa Hassan Elnaggar

Current Primary Outcome: oral mucosal lesion [ Time Frame: 10 minutes ]

Clinical examination according to WHO guidelines


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: March 3, 2017
Date Started:
Date Completion:
Last Updated: March 7, 2017
Last Verified: March 2017