Levels of Neuregulin-4 and Its Receptor ErbB4 in Periodontitis Patients With and Without Diabetes Type 2

NCT ID: NCT04930588

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-12-31

Brief Summary

The aim of this study is to assess the levels of neuregulin-4 and its receptor ErbB4 in the GCF and saliva in stage III and IV periodontitis patients with and without type 2 diabetes mellitus.

Detailed Description

The aim of this study is to measure the levels of Nrg4 and ErbB4 in the GCF and saliva of periodontitis stage III and IV patients with and without type 2 diabetes mellitus and to correlate their levels with the periodontal clinical parameters and the blood glucose levels including the fasting plasma glucose level (FPG) and glycated hemoglobin (HbA1c).

This study will be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry- Cairo University, Egypt.

Patients will be selected from the outpatient clinic of the department of Oral Medicine and Periodontology, Faculty of Dentistry-Cairo University.

Conditions

Periodontitis; Diabetes Mellitus

Study Design

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

Eligibility Criteria

Inclusion Criteria

• For periodontitis stage III and IV patients according to (Papapanou et al., 2018 and Tonetti et al., 2018)

1. Bleeding on probing (BOP) ≥ 30%.

2. At least four non-adjacent teeth sites in each jaw having CAL ≥ 5 mm and PD ≥ 6 mm in one or more sites.

3. Tooth loss due to periodontitis ≥ 5 teeth.

4. Presence of a minimum of 15 natural teeth. For diabetes and non-diabetic patients according to ("Diagnosis and Classification of Diabetes Mellitus," 2014)

5. Patients with type 2 diabetes mellitus will be diagnosed as having type 2 diabetes mellitus ≥ 5 years before the study and treated with stable doses of oral hypoglycaemic agents and/or insulin under the supervision of an endocrinologist with their glycated haemoglobin level (HBA1c) > 6%.

6. Non diabetic Patients in the control and stage III and IV periodontitis groups will be selected as having Fasting plasma glucose (FPG) <126 mg/dL.

Exclusion Criteria

1. Individuals with any known systemic disease other than type 2 diabetes.

2. Pregnant and lactating women.

3. Individuals that received periodontal treatment within the last 6 months.

4. Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.

5. Former or current smokers.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa Samir Abdel Fatah

Asmaa Samir

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asmaa samir, master

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo university Faculty of dentistry

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Asmaa Samir, Master

Role: CONTACT

Asmaaabdelfatah@dentistry.cu.edu.eg

01000797021

Facility Contacts

Asmaa Samir, Master

Role: primary

Asmaaabdelfatah@dentistry.cu.edu.eg

01000797021

Other Identifiers

PER7-2-1

Identifier Type: -

Identifier Source: org_study_id