Oral Findings in Chronic Kidney Disease

March 16, 2017 updated by: Maryam Ahmed Essam Abdel Salam

Prevalence of Oral Findings in Adult Patients With Chronic Kidney Disease '' Cross Sectional 2 "

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

Study Overview

Status

Unknown

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.

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

Observational

Enrollment (Anticipated)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
end stage renal disease
pre-dialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral mucosal lesions
Time Frame: 15 minutes
Clinical examination according to WHO guidelines
15 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: 10 minutes
HCV antibodies in patient blood
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maryam Ahmed Essam Abdel Salam

Collaborators

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

March 30, 2018

Study Registration Dates

First Submitted

March 12, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 17, 2017

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • renal_oral findings

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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