- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03074188
Prevalence of Oral Findings in Chronic Kidney Disease
Prevalence of Oral Findings in Adult Patients With Chronic Kidney Disease "Cross Sectional
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: alaa elnaggar, BDS
- Phone Number: 01204993009 01007802767
- Email: alaa_hassan@dentistry.cu.edu.eg
Study Contact Backup
- Name: Gihane Madkour
- Phone Number: 01121001005
- Email: gihanemadkour@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients >18 years old with a diagnosis of non-dialysis chronic kidney disease at stage 2, 3 and 4.
- Adult patients >18 years old with a diagnosis of end stage renal disease "stage 5".
- Recorded data of Glomerular Filtration Rate for every patient.
- Recorded data for dialysis patients (HCV, platelets count, creatinine, blood urea nitrogen, urea level and partial thromboplastin time).
Exclusion Criteria:
- Adult patients <18 years.
- End stage renal disease undergoing peritoneal dialysis.
- Patients not physically able to participate in oral examination.
- Patients with kidney transplantation.
- Patients undergoing renal dialysis for reasons other than chronic kidney disease, such as acute renal failure, accidents, trauma, snake poisoning.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
pre-dialysis patients
|
end stage renal disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
oral mucosal lesion
Time Frame: 10 minutes
|
Clinical examination according to WHO guidelines
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
.Periodontal condition
Time Frame: 10 minutes
|
Basic periodontal examination
|
10 minutes
|
Hepatitis C Virus at dialysis stage
Time Frame: 5 minutes
|
HCV antibodies in patient blood
|
5 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Mariam fakhr, the Nephrology units at the Kasr Al-Ainy Cairo university hospital.
Publications and helpful links
Study record dates
Study Major Dates
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- kidney _oral findings
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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