Kidney Disease, ChronicNCT03590067
Oral Findings in a Group of Egyptian Pediatric Patients at Endstage Renal Disease
An observational study of Kidney Disease, Chronic, run by Cairo University.
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 . Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Kidney Disease, Chronic
- What is being tested?
- Questionnaire
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- Child
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.
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: Oral Findings in a Group of Egyptian Pediatric Patients at Endstage Renal Disease Either on Haemodialysis or After Renal Transplantation
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.
Read the detailed 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)
- Conditions
- Kidney Disease, Chronic
- Being tested
- Questionnaire
- Keywords
- End stage renal disease, Haemodialysis, Renal transplantation, pediatric, chronic kidney disease, oral finding, oral manifestation
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Oral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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
| Study group | Role | What they receive |
|---|---|---|
| Heamodialysis group | Not described Receives: Other: Questionnaire | |
| Kidney transplantation group | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries
Clinical examination will be done and Caries index will be used ,Unit is the tooth to determine if there is caries or not
Measured: Five minutes
Secondary outcomes (3)
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
Measured: Ten minutes
Oral candidiasis
Clinical examination will be conducted to assess oral candidiasis and recorded by use of Lehner Oral Candidiasis Classification
Measured: Five minutes
Gingival overgrowth
Clinical examination will be done to asess gingival overgrowth and recorded by use of Angelopoulos and Goaz index
Measured: Five minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 Nov 2019 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Disease, ChronicStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahma Ali Saber Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590067
- Sponsor's protocol ID
- CEBD-CU-2018-06-26
- Status last verified
- Jul 2019
- First submitted
- 29 Jun 2018
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Findings in a Group of Egyptian Pediatric Patients at Endstage Renal Disease Either on Haemodialysis or After Renal Transplantation
- ClinicalTrials.gov ID
- NCT03590067
- Acronym / sponsor ID
- CEBD-CU-2018-06-26
- Conditions
- Kidney Disease, Chronic
- Keywords
- End stage renal disease, Haemodialysis, Renal transplantation, pediatric, chronic kidney disease, oral finding, oral manifestation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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)
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heamodialysis group | – | Other: Questionnaire |
| Kidney transplantation group | – | Other: Questionnaire |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireThe data will be collected through a questionnaire that will be obtained through an interview between the investigator and the parent or the legal guardian | Other | Heamodialysis group, Kidney transplantation group |
Primary outcome
Caries
Time frame: Five minutes
Clinical examination will be done and Caries index will be used ,Unit is the tooth to determine if there is caries or not
3 secondary outcomes
Enamel hypoplasia
Time frame: Ten minutes
Oral candidiasis
Time frame: Five minutes
Gingival overgrowth
Time frame: Five minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease, Chronic, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries (time frame: Five minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.