Prevalence of Oral Findings in Chronic Kidney Disease

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Diseases; Oral Disease

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: Observational
• Enrollment (Anticipated): 225

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: 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

How is the study designed?

Number of groups / cohorts

2

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	Clinical examination according to WHO guidelines	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
.Periodontal condition	Basic periodontal examination	10 minutes
Hepatitis C Virus at dialysis stage	HCV antibodies in patient blood	5 minutes

Collaborators and Investigators

• Sponsor: Alaa Mostafa Hassan Elnaggar
• Collaborators: Cairo University
• Investigators: Study Chair: Mariam fakhr, the Nephrology units at the Kasr Al-Ainy Cairo university hospital.

Publications and helpful links

General Publications

• Gautam NR, Gautam NS, Rao TH, Koganti R, Agarwal R, Alamanda M. Effect of end-stage renal disease on oral health in patients undergoing renal dialysis: A cross-sectional study. J Int Soc Prev Community Dent. 2014 Sep;4(3):164-9. doi: 10.4103/2231-0762.142006.

Study record dates

Study Major Dates

• Primary Completion (ANTICIPATED): May 30, 2018

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (ACTUAL): March 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: oral findings or oral manifestation; pre-dialysis stage or end stage renal disease
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Stomatognathic Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Mouth Diseases
• Other Study ID Numbers: kidney _oral findings

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED