- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03590067
Oral Findings in a Group of Egyptian Pediatric Patients at Endstage Renal Disease
Oral Findings in a Group of Egyptian Pediatric Patients at Endstage Renal Disease Either on Haemodialysis or After Renal Transplantation
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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)
Studientyp
Einschreibung (Voraussichtlich)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
Heamodialysis group
|
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
|
Kidney transplantation group
|
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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Caries
Zeitfenster: 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
|
Five minutes
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Enamel hypoplasia
Zeitfenster: Ten minutes
|
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
|
Oral candidiasis
Zeitfenster: Five minutes
|
Clinical examination will be conducted to assess oral candidiasis and recorded by use of Lehner Oral Candidiasis Classification
|
Five minutes
|
Gingival overgrowth
Zeitfenster: Five minutes
|
Clinical examination will be done to asess gingival overgrowth and recorded by use of Angelopoulos and Goaz index
|
Five minutes
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CEBD-CU-2018-06-26
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .