Prevalence Of Oral Mucosal Alterations In Diabetes Mellitus Type2

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670797
• Other study ID #: Diabetes-Oral Alterations
• Status: Completed
• Start date: December 25, 2018
• Est. completion date: August 20, 2019

Study information

• Verified date: January 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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the investigator and the patient.Clinical examination will be performed for the oral cavity.Blood sample will be withdrawn from each participant and collected in the clinical pathology lab in El kasr Al Ainy to measure the glycosylated hemoglobin concentration.The salivary gland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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 20, 2019
• Est. primary completion date: July 30, 2019
• Gender: All
• Age group: 25 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Oral Disease

Locations

Country	Name	City	State
Egypt	Alaa Mahmoud Abd El Kader	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Alaa Mahmoud abd El kader	Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Al-Maweri SA, Ismail NM, Ismail AR, Al-Ghashm A. Prevalence of oral mucosal lesions in patients with type 2 diabetes attending hospital universiti sains malaysia. Malays J Med Sci. 2013 Jul;20(4):39-46. — View Citation

Bastos AS, Leite AR, Spin-Neto R, Nassar PO, Massucato EM, Orrico SR. Diabetes mellitus and oral mucosa alterations: prevalence and risk factors. Diabetes Res Clin Pract. 2011 Apr;92(1):100-5. doi: 10.1016/j.diabres.2011.01.011. Epub 2011 Mar 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral mucosal alterations	Clinical examination according to WHO guidelines by Dichotomous outcome (Yes/No).	10 min
Secondary	Periodontal condition	Basic periodontal examination by Continuous outcome (Score codes).	10 min
Secondary	Salivary glands function	Clinical oral dryness examination and Self estimated questionnaire by Dichotomous outcome (Yes/No).	10 min