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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yara Yousif Kairi
- Phone Number: +201555003176
- Email: Yara.kairi@dentistry.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: OTHER
- Time Perspectives: CROSS_SECTIONAL
Cohorts and Interventions
Group / Cohort |
|---|
|
Group 1: diabetic participants
Participants with HbA1c ≥6.5% |
|
Group 2: non-diabetic participants
Participants with HbA1c <6.5%. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of apical periodontitis
Time Frame: 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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24.9.2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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