Alaa Mahmoud Abd El Kader
Cairo, 2020, Egypt
NCT Number: NCT03670797
There are severe deficiency of database concerning the oral health status in Egyptian patients with Diabetes type 2. Our aim in the present study is to study the prevalence of oral mucosal alterations in type 2 DM patients and the effect of hyperglycemia on these alterations in controlled and uncontrolled patients to increase their awareness and minimize all the possible risk factors,to achieve a proper management for all oral problems.
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Notify Me25 year–90 year
All sexes
Observational
Cairo, 2020, Egypt
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the investigator and the patient.Clinical examination will be performed for the oral cavity.Blood sample will be withdrawn from each participant and collected in the clinical pathology lab in El kasr Al Ainy to measure the glycosylated hemoglobin concentration.The salivary gland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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 10 min
Clinical examination according to WHO guidelines by Dichotomous outcome (Yes/No).
Time frame: 10 min
Basic periodontal examination by Continuous outcome (Score codes).
Time frame: 10 min
Clinical oral dryness examination and Self estimated questionnaire by Dichotomous outcome (Yes/No).
Alaa Mahmoud abd El kader
Other
Prevalence Of Oral Mucosal Alterations In a Sample of Egyptian Patients With Diabetes Mellitus Type2: A Hospital Based Cross Sectional Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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