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Prevalence Of Oral Mucosal Alterations In Diabetes Mellitus Type2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03670797
Recruitment Status : Enrolling by invitation
First Posted : September 14, 2018
Last Update Posted : March 19, 2019
Cairo University
Information provided by (Responsible Party):
Alaa Mahmoud abd El kader, Cairo University

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the investigator and the patient.Clinical examination will be performed for the oral cavity.Blood sample will be withdrawn from each participant and collected in the clinical pathology lab in El kasr Al Ainy to measure the glycosylated hemoglobin concentration.The salivary gland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

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Study Type : Observational
Estimated Enrollment : 381 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 : December 25, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : September 20, 2019

Resource links provided by the National Library of Medicine

controlled diabetic patients
uncontrolled diabetic patients

Primary Outcome Measures :
  1. Oral mucosal alterations [ Time Frame: 10 min ]
    Clinical examination according to WHO guidelines by Dichotomous outcome (Yes/No).

Secondary Outcome Measures :
  1. Periodontal condition [ Time Frame: 10 min ]
    Basic periodontal examination by Continuous outcome (Score codes).

  2. Salivary glands function [ Time Frame: 10 min ]
    Clinical oral dryness examination and Self estimated questionnaire by Dichotomous outcome (Yes/No).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Inclusion Criteria:

  1. Adult patients
  2. Patients >18 years old
  3. Patients diagnosed with diabetes type 2.
  4. Egyptian patients.

Exclusion Criteria:

  1. Pregnant females (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 renal and liver disorders.
  4. Patients under immunosuppressive drugs.
  5. Patients under corticosteriods.
  6. Patients with organ transplantation.
  7. smokers patients.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03670797

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Alaa Mahmoud Abd El Kader
Cairo, Egypt, 2020
Sponsors and Collaborators
Alaa Mahmoud abd El kader
Cairo University
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Study Chair: Mariam fakhr the Endocrine units at the Kasr Al-Ainy Cairo university hospital.

Publications of Results:
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Responsible Party: Alaa Mahmoud abd El kader, principle investigator, internal resident at oral medicine department, Cairo University Identifier: NCT03670797     History of Changes
Other Study ID Numbers: Diabetes-Oral Alterations
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alaa Mahmoud abd El kader, Cairo University:
oral health status
oral findings
oral manifestations
patients with diabetes

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Mouth Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomatognathic Diseases