Oral Findings in Chronic Kidney Disease

NCT ID: NCT03082365

Last Updated: 2017-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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

Detailed Description

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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

Conditions

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Oral Disease Chronic Kidney Diseases

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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pre-dialysis

No interventions assigned to this group

end stage renal disease

No interventions assigned to this group

Eligibility Criteria

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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

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Cairo University

OTHER

Sponsor Role collaborator

Maryam Ahmed Essam Abdel Salam

OTHER

Sponsor Role lead

Responsible Party

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Maryam Ahmed Essam Abdel Salam

BDS internal resident at oral medicine department

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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maryam abdelsalam, BDS

Role: CONTACT

01100686304

gihane madkour

Role: CONTACT

References

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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 BACKGROUND
PMID: 25374834 (View on PubMed)

Other Identifiers

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renal_oral findings

Identifier Type: -

Identifier Source: org_study_id

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