Prevalence of Oral Findings in Chronic Kidney Disease

NCT ID: NCT03074188

Last Updated: 2017-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 225 participants
• Study Classification: OBSERVATIONAL

Brief 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.

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.

Conditions

Oral Disease; Chronic Kidney Diseases

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

pre-dialysis patients

No interventions assigned to this group

end stage renal disease

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Alaa Mostafa Hassan Elnaggar

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mostafa Hassan Elnaggar

internal resident at oral medicine department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mariam fakhr

Role: STUDY_CHAIR

the Nephrology units at the Kasr Al-Ainy Cairo university hospital.

Central Contacts

alaa elnaggar, BDS

Role: CONTACT

alaa_hassan@dentistry.cu.edu.eg

01007802767 ext. 01204993009

Gihane Madkour

Role: CONTACT

gihanemadkour@gmail.com

01121001005

References

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.

Reference Type: RESULT

PMID: 25374834 (View on PubMed)

Other Identifiers

kidney _oral findings

Identifier Type: -

Identifier Source: org_study_id