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

Diabetes Mellitus Clinical Trial

Official title:

Gingival Crevicular Fluid and Salivary Levels of Neuregulin-4 and Its Receptor ErbB4 in Patients With Stage III and IV Periodontitis With and Without Type 2 Diabetes: An Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04930588
• Other study ID #: PER7-2-1
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: June 2021
• Source: Cairo University
• Contact: Asmaa Samir, Master
• Phone: 01000797021
• Email: Asmaaabdelfatah[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Periodontitis

Locations

Country	Name	City	State
Egypt	Cairo university Faculty of dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuregulin-4 in the GCF	Measured by Enzyme-Linked Immunosorbent Assay in µL	6 month
Primary	The receptor ErbB4 in the GCF	Measured by Enzyme-Linked Immunosorbent Assay in µL	6 month
Primary	Neuregulin-4 in the saliva	Measured by Enzyme-Linked Immunosorbent Assay in µL	6 month
Primary	The receptor ErbB4 in saliva	Measured by Enzyme-Linked Immunosorbent Assay in µL	6 month
Secondary	Pocket depth	Measured by Manual UNC periodontal probe in mm	6 month
Secondary	Clinical attachment level	Measured by Manual UNC periodontal probe in mm	6 month
Secondary	Bleeding on probing	Measured by Manual UNC periodontal probe by gently probing the orifice of the gingival crevice, the periodontal probe will be inserted 1 to2 mm into the gingival sulcus starting at one interproximal area and moving to the other. If bleeding occurs within 10 seconds a positive finding is recorded.	6 month
Secondary	plaque index	Measured by Manual UNC periodontal probe Scores: 0: No plaque; A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of a disclosing solution or by using the probe on the tooth surface.; Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye.; Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.	6 month
Secondary	Glycosylated Haemoglobin (HbA1c %)	Measured by High performance liquid chromatography in mmol/mol	6 month
Secondary	Fasting plasma Glucose Level (FPG)	Measured by blood sampling in (mg/dl)	6 month
Secondary	Body Mass Index (BMI)	Measured in (Kg/m2)	6 month