- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07856186
Apical Periodontitis and Glycemic Control in Diabetic and Non-diabetic Egyptian Sub-population
Prevalence of Apical Periodontitis and it's Association With Glycemic Control in Diabetic and Non-diabetic Egyptian Sub-population: A Cross-sectional Study
This observational cross-sectional study aims to assess the prevalence of apical periodontitis in diabetic and non-diabetic adult Egyptian patients and to evaluate its association with glycemic control measured by glycated hemoglobin (HbA1c). Participants will undergo clinical examination, digital panoramic radiographic assessment, and HbA1c measurement.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Apical periodontitis is an inflammatory disease of the periapical tissues that develops as a consequence of endodontic infection. Diabetes mellitus has been associated with an increased prevalence of apical periodontitis, although the available evidence remains limited and inconsistent. In addition, the relationship between glycemic control and apical periodontitis remains unclear, and population-specific data in Egypt are limited.
This observational cross-sectional study will assess the prevalence of apical periodontitis in diabetic and non-diabetic adult Egyptian patients and evaluate the association between glycemic control and apical periodontitis. Participants will be recruited from outpatient dental clinics of the Endocrine and Diabetes Center in Cairo, Egypt, in collaboration with the Department of Endodontics, Faculty of Dentistry, Cairo university.
Eligible participants will be Egyptian males and females aged 21 years or older with at least eight teeth present. Participants will undergo standardized clinical oral examination, digital panoramic radiographic examination, and measurement of glycated hemoglobin (HbA1c). Apical periodontitis will be assessed radiographically based on the presence or absence of periapical radiolucency. Participants will be classified into diabetic and non-diabetic groups according to HbA1c levels.
The primary objective is to assess the prevalence of apical periodontitis in diabetic and non-diabetic patients. The secondary objective is to evaluate the association between HbA1c levels and the presence of apical periodontitis. The planned sample size is 88 participants, with 44 participants in each group.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Yara Yousif Kairi
- Numero di telefono: +201555003176
- Email: Yara.kairi@dentistry.cu.edu.eg
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Adult Egyptian male and female patients aged 21 years or older with at least 8 teeth, recruited from outpatient dental clinics at the Faculty of Dentistry, Cairo University and the Endocrine and Diabetes Center, Cairo, Egypt. Participants will be classified into diabetic and non-diabetic groups based on their measured HbA1c levels.
Descrizione
Inclusion Criteria:
- Adult Egyptian males and females
- 21 years or older
- At least 8 teeth present
- Willing to undergo clinical and radiographic examination, HbA1c measurement, -Willing to provide informed consent.
Exclusion Criteria:
- Participants younger than 21 years
- fewer than 8 teeth
- Those who refuse clinical or radiographic examination
- Patients with systemic diseases other than diabetes that may affect oral or periapical health.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: OTHER
- Prospettive temporali: CROSS_SECTIONAL
Coorti e interventi
Gruppo / Coorte |
|---|
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Group 1: diabetic participants
Participants with HbA1c ≥6.5% |
|
Group 2: non-diabetic participants
Participants with HbA1c <6.5%. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Prevalence of apical periodontitis
Lasso di tempo: During the 6-month study/recruitment period.
|
Presence or absence of apical periodontitis assessed by digital panoramic radiographic examination using binary scoring based on the presence of periapical radiolucency. |
During the 6-month study/recruitment period.
|
Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 24.9.2024
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Individual participant data will not be shared with individual researchers outside the study team. Study data will be accessible to the Principal Investigator and supervisors and will be protected to maintain participant confidentiality.
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