Prevalence Of Oral Mucosal Alterations In Diabetes Mellitus Type2
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|ClinicalTrials.gov Identifier: NCT03670797|
Recruitment Status : Enrolling by invitation
First Posted : September 14, 2018
Last Update Posted : March 19, 2019
|Condition or disease|
|Oral Disease Diabetes|
The study will be held in the Endocrine clinic at El Kasr Al-Ainy Cairo University Hospital for patients with diabetes mellitus type2. The data collected through the questionnaire will be obtained through an interview between the investigator and the patient.Clinical examination will be performed for the oral cavity.Blood sample will be withdrawn from each participant and collected in the clinical pathology lab in El kasr Al Ainy to measure the glycosylated hemoglobin concentration.The salivary gland function will be determined through a small questionnaire and clinical examination of the patient.
Selection bias: will be minimized by enrolling the participants in the study in a consecutive order of the entering the clinic.
Non-respondent bias: will be minimized by explaining to the participants the aim of the study and their importance and role in the study.
Incomplete records: will be excluded from statistical analysis with reporting the cause of not completing the record.
Sample size estimation:
Based on the previous papers by AL-Maweri,et al ,2013, the prevalence of oral mucosal alterations in diabetic patients 45.1%.Using a precision of 5, a design effect set at 1 with 95% CI (confidence interval), a total sample size of 381 will be sufficient. The sample size was calculated by Epi info.
|Study Type :||Observational|
|Estimated Enrollment :||381 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Prevalence Of Oral Mucosal Alterations In a Sample of Egyptian Patients With Diabetes Mellitus Type2: A Hospital Based Cross Sectional Study|
|Actual Study Start Date :||December 25, 2018|
|Estimated Primary Completion Date :||July 30, 2019|
|Estimated Study Completion Date :||September 20, 2019|
|controlled diabetic patients|
|uncontrolled diabetic patients|
- Oral mucosal alterations [ Time Frame: 10 min ]Clinical examination according to WHO guidelines by Dichotomous outcome (Yes/No).
- Periodontal condition [ Time Frame: 10 min ]Basic periodontal examination by Continuous outcome (Score codes).
- Salivary glands function [ Time Frame: 10 min ]Clinical oral dryness examination and Self estimated questionnaire by Dichotomous outcome (Yes/No).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670797
|Alaa Mahmoud Abd El Kader|
|Cairo, Egypt, 2020|
|Study Chair:||Mariam fakhr||the Endocrine units at the Kasr Al-Ainy Cairo university hospital.|