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

Kidney Disease, Chronic Clinical Trial

Official title:

Oral Findings in a Group of Egyptian Pediatric Patients at Endstage Renal Disease Either on Haemodialysis or After Renal Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03590067
• Other study ID #: CEBD-CU-2018-06-26
• Status: Not yet recruiting
• Start date: November 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Study setting:

• The study will be held at the center of Pediatric Nephrology and transplantation, El- Mounira children's hospital (Abu El rish).

• The data collected through the questionnaire will be obtained through an interview between the investigator and the parent or the legal guardian that's based on WHO guide for health surveys(WHO Oral health surveys, 2013)

• For patients undergoing dialysis, examination will be performed at the dialysis unit during dialysis session (there is no waiting room for patients before dialysis).

• For patients who received renal transplantation, examination will be performed at the outpatient nephrology clinic during follow up visits.

• Clinical examination will be performed for both oral (soft tissue) and dental (hard) tissue.

• Decayed-Missing-Filled Index ( DMF ) which was introduced by Klein, Palmer and Knutson in 1938 and modified by WHO.

The components are:

D component:

Used to describe (Decayed teeth) which include:

Carious tooth. Filled tooth with recurrent decay. Only the roots are left. Defect filling with caries. Temporary filling. Filled tooth surface with other surface decayed.

M component:

Used to describe (Missing teeth due to caries) other cases should be excluded.

F component:

Used to describe (Filled teeth due to caries). Teeth were considered filled without decay when one or more permanent restorations were present and there was no secondary (recurrent) caries or other area of the tooth with primary caries. A tooth with a crown placed because of previous decay was recorded in this category. Teeth stored for reason other than dental caries should be excluded.

deft / defs , which was introduced by Gruebbel in 1944

d- decayed tooth . e- decayed tooth indicated for extraction . f- filled tooth

• The coding system for the Modified DDE Index has three items of information that will be recorded for each tooth surface. (Clarkson and O'Mullane, 1989)

First, the Type of Defect, codes 0-7, was recorded. Then the Sub-type of that defect was noted, i.e., when a demarcated opacity was present, the Sub-type was either white/cream (code 1) or yellow/brown (code 2), or when a diffuse opacity was present, then six options were possible. Finally, the extent of each defect was recorded. The new additional sub-type (code 3) termed "diffuse confluent opacity" is defined as a diffuse opacity in which any patchiness has merged into a regular condensed chalky white area, and it could cover the entire surface of a tooth or be confined to a localized area of the tooth surface.

• Oral candidiasis assessment will be based on the Lehner scale (Cleverson et al., 2014)

• In assessing the degree of gingival hyperplasia we will use the index of Angelopoulos and Goaz, described by Prof. T. Djemileva. (Dencheva et al., 2011)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 1, 2020
• Est. primary completion date: December 1, 2019
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

Inclusion Criteria:

1. Pediatric patients <15 years old with a diagnosis of end stage renal disease "stage 5" receiving dialysis.

2. Pediatric Patients < 15 years old with kidney transplantation in the monthly follow up.

3. Recorded data for every patient. (Glomerular Filtration Rate, Creatinine level, urea level and calcium level).

Exclusion Criteria:

1. Patients undergoing renal dialysis for reasons other than chronic kidney disease, such as acute renal failure secondary to accidents, trauma, snake poisoning.

2. Patients undergoing peritoneal dialysis.

3. Patients not physically able to participate in the examination.

4. Chronic kidney disease patients at stage 2, 3 and 4.

Related Conditions & MeSH terms

• Chronic Disease
• Kidney Disease, Chronic
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Other:
• Questionnaire
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Enamel hypoplasia	Clinical examination will be done on each patient to assess enamel hypoplasia and recorded by use of Modified Developmental Defect of Enamel (DDE) Index	Ten minutes
Secondary	Oral candidiasis	Clinical examination will be conducted to assess oral candidiasis and recorded by use of Lehner Oral Candidiasis Classification	Five minutes
Secondary	Gingival overgrowth	Clinical examination will be done to asess gingival overgrowth and recorded by use of Angelopoulos and Goaz index	Five minutes