Clinical trial NCT03670797: Prevalence Of Oral Mucosal Alterations In Diabetes Mellitus Type2
Official title: Prevalence Of Oral Mucosal Alterations In a Sample of Egyptian Patients With Diabetes Mellitus Type2: A Hospital Based Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Disease
Diabetes
Keywords: oral health status
oral findings
oral manifestations
patients with diabetes
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2018-09-14
Enrollment: 500
Sex: ALL
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A convenience sample of adult patients diagnosed with diabetes type 2 attending at the Endocrine clinic at El Kasr Al-Ainy Cairo University Hospital will be enrolled in the study in a consecutive order.

Brief summary: 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.

Detailed description: 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the investigator and the patient.Clinical examination will be performed for the oral cavity.Blood sample will be withdrawn from each participant and collected in the clinical pathology lab in El kasr Al Ainy to measure the glycosylated hemoglobin concentration.The salivary gland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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients
2. Patients \>25years old
3. Patients diagnosed with diabetes type 2.
4. Egyptian patients.

Exclusion Criteria:

1. females diagnosed with gestational diabetes.
2. Patients not physically able to participate in survey or clinical oral examination.
3. Patients with other systemic diseases which may cause oral manifestation as liver disorders.
4. Patients under immunosuppressive drugs.
5. Patients under corticosteriods.
6. Patients with organ transplantation.

Primary outcomes:
measure: Oral mucosal alterations
timeFrame: 10 min
Secondary outcomes:
measure: Periodontal condition
timeFrame: 10 min
measure: Salivary glands function
timeFrame: 10 min
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alaa Mahmoud Abd El Kader
Study officials:
affiliation: the Endocrine units at the Kasr Al-Ainy Cairo university hospital.
name: Mariam fakhr
role: STUDY_CHAIR
References:
citation: Al-Maweri SA, Ismail NM, Ismail AR, Al-Ghashm A. Prevalence of oral mucosal lesions in patients with type 2 diabetes attending hospital universiti sains malaysia. Malays J Med Sci. 2013 Jul;20(4):39-46.
citation: Bastos AS, Leite AR, Spin-Neto R, Nassar PO, Massucato EM, Orrico SR. Diabetes mellitus and oral mucosa alterations: prevalence and risk factors. Diabetes Res Clin Pract. 2011 Apr;92(1):100-5. doi: 10.1016/j.diabres.2011.01.011. Epub 2011 Mar 3.