Prevalence of Oral Findings in Chronic Kidney Disease

Sponsor

Alaa Mostafa Hassan Elnaggar (Other)

Overall Status

Unknown status

CT.gov ID

NCT03074188

Collaborator

Cairo University (Other)

225

Enrollment

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Disease Chronic Kidney Diseases

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

225 participants

Observational Model:

Ecologic or Community

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Primary Completion Date :

May 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
pre-dialysis patients
end stage renal disease

Outcome Measures

Primary Outcome Measures

oral mucosal lesion [10 minutes]
Clinical examination according to WHO guidelines

Secondary Outcome Measures

.Periodontal condition [10 minutes]
Basic periodontal examination
Hepatitis C Virus at dialysis stage [5 minutes]
HCV antibodies in patient blood

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Adult patients >18 years old with a diagnosis of non-dialysis chronic kidney disease at stage 2, 3 and 4.
Adult patients >18 years old with a diagnosis of end stage renal disease "stage 5".
Recorded data of Glomerular Filtration Rate for every patient.
Recorded data for dialysis patients (HCV, platelets count, creatinine, blood urea nitrogen, urea level and partial thromboplastin time).

Exclusion Criteria:

Adult patients <18 years.
End stage renal disease undergoing peritoneal dialysis.
Patients not physically able to participate in oral examination.
Patients with kidney transplantation.
Patients undergoing renal dialysis for reasons other than chronic kidney disease, such as acute renal failure, accidents, trauma, snake poisoning.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Alaa Mostafa Hassan Elnaggar
Cairo University

Investigators

Study Chair: Mariam fakhr, the Nephrology units at the Kasr Al-Ainy Cairo university hospital.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alaa Mostafa Hassan Elnaggar, internal resident at oral medicine department, Cairo University

ClinicalTrials.gov Identifier:

NCT03074188

Other Study ID Numbers:

kidney _oral findings

First Posted:

Mar 8, 2017

Last Update Posted:

Mar 8, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Alaa Mostafa Hassan Elnaggar, internal resident at oral medicine department, Cairo University

oral findings or oral manifestation

pre-dialysis stage or end stage renal disease

Additional relevant MeSH terms:

Mouth Diseases

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Mar 8, 2017