Prevalence Of Oral Mucosal Alterations In Diabetes Mellitus Type2

January 25, 2020 updated by: Alaa Mahmoud abd El kader

Prevalence Of Oral Mucosal Alterations In a Sample of Egyptian Patients With Diabetes Mellitus Type2: A Hospital Based Cross Sectional Study

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.

Study Overview

Status

Completed

Conditions

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the investigator and the patient.Clinical examination will be performed for the oral cavity.Blood sample will be withdrawn from each participant and collected in the clinical pathology lab in El kasr Al Ainy to measure the glycosylated hemoglobin concentration.The salivary gland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

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 2020
        • Alaa Mahmoud Abd El Kader

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
controlled diabetic patients
uncontrolled diabetic patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral mucosal alterations
Time Frame: 10 min
Clinical examination according to WHO guidelines by Dichotomous outcome (Yes/No).
10 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal condition
Time Frame: 10 min
Basic periodontal examination by Continuous outcome (Score codes).
10 min
Salivary glands function
Time Frame: 10 min
Clinical oral dryness examination and Self estimated questionnaire by Dichotomous outcome (Yes/No).
10 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alaa Mahmoud abd El kader

Collaborators

Cairo University

Investigators

  • Study Chair: Mariam fakhr, the Endocrine units at the Kasr Al-Ainy Cairo university hospital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2018

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

August 20, 2019

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (Actual)

September 14, 2018

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 25, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diabetes-Oral Alterations

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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