Prevalence of Oral Findings in Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03074188
• Other study ID #: kidney _oral findings
• Status: Not yet recruiting
• Phase: N/A
• First received: March 3, 2017
• Last updated: March 7, 2017

Study information

• Verified date: March 2017
• Source: Cairo University
• Contact: alaa elnaggar, BDS
• Phone: 01007802767
• Email: alaa_hassan[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. primary completion date: May 30, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Mouth Diseases
• Oral Disease
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alaa Mostafa Hassan Elnaggar	Cairo University

References & Publications (1)

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: 10.4103/2231-0762.142 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oral mucosal lesion	Clinical examination according to WHO guidelines	10 minutes
Secondary	.Periodontal condition	Basic periodontal examination	10 minutes
Secondary	Hepatitis C Virus at dialysis stage	HCV antibodies in patient blood	5 minutes