Prevalence Of Oral Mucosal Alterations In Diabetes Mellitus Type2

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03670797

Enrollment

500

Registered

2018-09-14

Start date

2018-12-25

Completion date

2019-08-20

Last updated

2020-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Oral Disease

Keywords

oral health status, oral findings, oral manifestations, patients with diabetes

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the investigator and the patient.Clinical examination will be performed for the oral cavity.Blood sample will be withdrawn from each participant and collected in the clinical pathology lab in El kasr Al Ainy to measure the glycosylated hemoglobin concentration.The salivary gland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

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

25 Years to 90 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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).

Countries

Egypt

Outcome results