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OpenTrials
Completed

NCT Number: NCT03670797

Prevalence Of Oral Mucosal Alterations In Diabetes Mellitus Type2

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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Key information

About this study

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the investigator and the patient.Clinical examination will be performed for the oral cavity.Blood sample will be withdrawn from each participant and collected in the clinical pathology lab in El kasr Al Ainy to measure the glycosylated hemoglobin concentration.The salivary gland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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Oral mucosal alterations

    Time frame: 10 min

    Clinical examination according to WHO guidelines by Dichotomous outcome (Yes/No).

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Alaa Mahmoud abd El kader

Other

Collaborators

  • Cairo University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 14, 2018
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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