Oral Findings in Chronic Kidney Disease | NCT03082365

Studies
Oral Findings in Chronic Kidney Disease

NCT03082365

Sponsor

Maryam Ahmed Essam Abdel Salam

Status

Unknown status

Last Update Posted

Mar 17, 2017Actual

Enrollment

225Estimated

Phase

Not provided

Conditions

Oral Disease
Chronic Kidney Diseases

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Mar 30, 2018Estimated

Completion Date

Not provided

First Submitted Date

Mar 12, 2017

First Submission Date that Met QC Criteria

Mar 16, 2017

First Posted Date

Mar 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2017

Last Update Posted Date

Mar 17, 2017Actual

Name	Class
Cairo University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

225Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oral mucosal lesions	Clinical examination according to WHO guidelines	15 minutes

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
maryam abdelsalam, BDS	Contact	01100686304		maryamessam20@gmail.com
gihane madkour	Contact			gihanemadkour@gmail.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25374834	Background	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.

ID	Term
D009059	Mouth Diseases
D051436	Renal Insufficiency, Chronic
D009912	Oral Manifestations
D007676	Kidney Failure, Chronic

ID	Term
D009057	Stomatognathic Diseases
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases