Oral Findings in a Group of Egyptian Pediatric Patients at Endstage Renal Disease

NCT03590067 | Unknown DMC

• 1 other identifier: CEBD-CU-2018-06-26
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

In Egypt, the prevalence of end stage renal disease in pediatric population has never been estimated on a national scale. The patients at end stage renal disease encounter oral and dental problems that emphasize regular and careful screening . In Egypt, the prevalence of oral findings is not studied so we conduct this study to study the oral findings among a group of pediatric patients at end stage renal disease either on haemodialysis or after kidney transplantation.

Conditions

Kidney Disease, Chronic

Keywords

End stage renal disease; Haemodialysis; Renal transplantation; pediatric; chronic kidney disease; oral finding; oral manifestation

Outcome Measures

Primary Outcomes (1)

• Caries

  Clinical examination will be done and Caries index will be used ,Unit is the tooth to determine if there is caries or not

  Five minutes

Secondary Outcomes (3)

• Enamel hypoplasia

  Ten minutes

• Oral candidiasis

  Five minutes

• Gingival overgrowth

  Five minutes

Study Arms (2)

Heamodialysis group

Other: Questionnaire

Kidney transplantation group

Other: Questionnaire

Interventions

Questionnaire OTHER

The data will be collected through a questionnaire that will be obtained through an interview between the investigator and the parent or the legal guardian

Heamodialysis group; Kidney transplantation group

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All pediatric patients at end stage renal disease attending at the center of Pediatric Nephrology and transplantation, El- Mounira children's hospital (Abu El rish) will be enrolled in the study in a consecutive order according to inclusion criteria.

You may qualify if:

• Pediatric patients \<15 years old with a diagnosis of end stage renal disease "stage 5" receiving dialysis.
• Pediatric Patients \< 15 years old with kidney transplantation in the monthly follow up.
• Recorded data for every patient. (Glomerular Filtration Rate, Creatinine level, urea level and calcium level).

You may not qualify if:

• Patients undergoing renal dialysis for reasons other than chronic kidney disease, such as acute renal failure secondary to accidents, trauma, snake poisoning.
• Patients undergoing peritoneal dialysis.
• Patients not physically able to participate in the examination.
• Chronic kidney disease patients at stage 2, 3 and 4.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Oral Manifestations

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 18, 2018
• Study Start: November 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: July 31, 2019

Record last verified: 2019-07