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Oral Findings in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03082365
Recruitment Status : Unknown
Verified March 2017 by Maryam Ahmed Essam Abdel Salam, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : March 17, 2017
Last Update Posted : March 17, 2017
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Maryam Ahmed Essam Abdel Salam, Cairo University

Brief Summary:
The patients with chronic kidney disease suffer from many oral problems affecting the quality of life. The aim of our study is to assess their oral health to provide the proper management and increase their awareness

Condition or disease
Oral Disease Chronic Kidney Diseases

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.

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


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Study Type : Observational
Estimated Enrollment : 225 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Prevalence of Oral Findings in Adult Patients With Chronic Kidney Disease '' Cross Sectional 2 "
Estimated Primary Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort
pre-dialysis
end stage renal disease



Primary Outcome Measures :
  1. Oral mucosal lesions [ Time Frame: 15 minutes ]
    Clinical examination according to WHO guidelines


Secondary Outcome Measures :
  1. Periodontal condition [ Time Frame: 10 minutes ]
    Basic periodontal examination

  2. Hepatitis C Virus at dialysis stage [ Time Frame: 10 minutes ]
    HCV antibodies in patient blood



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
A convenience sample of adult patients diagnosed with chronic kidney disease attending at the Nephrology units at El Kasr Al-Ainy Cairo University Hospital will be enrolled in the study in a consecutive order
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082365


Contacts
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Contact: maryam abdelsalam, BDS 01100686304 maryamessam20@gmail.com
Contact: gihane madkour gihanemadkour@gmail.com

Sponsors and Collaborators
Maryam Ahmed Essam Abdel Salam
Cairo University

Publications:
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Responsible Party: Maryam Ahmed Essam Abdel Salam, BDS internal resident at oral medicine department, Cairo University
ClinicalTrials.gov Identifier: NCT03082365     History of Changes
Other Study ID Numbers: renal_oral findings
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Maryam Ahmed Essam Abdel Salam, Cairo University:
oral findings or oral manifestations
pre-dialysis or end stage renal disease

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Mouth Diseases
Urologic Diseases
Renal Insufficiency
Stomatognathic Diseases