Prevalence Of Oral Mucosal Alterations In Diabetes Mellitus Type2

NCT ID: NCT03670797

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-25
• Study Completion Date: 2019-08-20

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the investigator and the patient.Clinical examination will be performed for the oral cavity.Blood sample will be withdrawn from each participant and collected in the clinical pathology lab in El kasr Al Ainy to measure the glycosylated hemoglobin concentration.The salivary gland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

Conditions

Oral Disease; Diabetes

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

controlled diabetic patients

No interventions assigned to this group

uncontrolled diabetic patients

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Alaa Mahmoud abd El kader

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mahmoud abd El kader

principle investigator, internal resident at oral medicine department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mariam fakhr

Role: STUDY_CHAIR

the Endocrine units at the Kasr Al-Ainy Cairo university hospital.

Locations

Alaa Mahmoud Abd El Kader

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: RESULT

PMID: 24043995 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21300417 (View on PubMed)

Other Identifiers

Diabetes-Oral Alterations

Identifier Type: -

Identifier Source: org_study_id