Oral Findings in Chronic Kidney Disease

Maryam Ahmed Essam Abdel Salam

Status: Unknown

Conditions: Chronic Kidney Diseases; Oral Disease

Study type: Observational

Funder types: Other

Identifiers

NCT03082365

renal_oral findings

Details and patient eligibility

About

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

Full 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

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

225 participants in 2 patient groups

pre-dialysis

end stage renal disease