Prevalence Of Oral Mucosal Alterations In Diabetes Mellitus Type2

Sponsor

Alaa Mahmoud abd El kader (Other)

Overall Status

Completed

CT.gov ID

NCT03670797

Collaborator

Cairo University (Other)

500

Enrollment

Location

7.8

Actual Duration (Months)

63.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Disease Diabetes

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the investigator and the patient.Clinical examination will be performed for the oral cavity.Blood sample will be withdrawn from each participant and collected in the clinical pathology lab in El kasr Al Ainy to measure the glycosylated hemoglobin concentration.The salivary gland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

Study Design

Study Type:

Observational

Actual Enrollment :

500 participants

Observational Model:

Ecologic or Community

Time Perspective:

Cross-Sectional

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 :

Dec 25, 2018

Actual Primary Completion Date :

Jul 30, 2019

Actual Study Completion Date :

Aug 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
controlled diabetic patients
uncontrolled diabetic patients

Outcome Measures

Primary Outcome Measures

Oral mucosal alterations [10 min]
Clinical examination according to WHO guidelines by Dichotomous outcome (Yes/No).

Secondary Outcome Measures

Periodontal condition [10 min]
Basic periodontal examination by Continuous outcome (Score codes).
Salivary glands function [10 min]
Clinical oral dryness examination and Self estimated questionnaire by Dichotomous outcome (Yes/No).

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 90 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Adult patients
Patients >25years old
Patients diagnosed with diabetes type 2.
Egyptian patients.

Exclusion Criteria:

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