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

NCT04930588 | Unknown DMC

• 1 other identifier: PER7-2-1
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• Neuregulin-4 in the GCF

  Measured by Enzyme-Linked Immunosorbent Assay in μL

  6 month

• The receptor ErbB4 in the GCF

  Measured by Enzyme-Linked Immunosorbent Assay in μL

  6 month

• Neuregulin-4 in the saliva

  Measured by Enzyme-Linked Immunosorbent Assay in μL

  6 month

• The receptor ErbB4 in saliva

  Measured by Enzyme-Linked Immunosorbent Assay in μL

  6 month

Secondary Outcomes (7)

• Pocket depth

  6 month

• Clinical attachment level

  6 month

• Bleeding on probing

  6 month

• plaque index

  6 month

• Glycosylated Haemoglobin (HbA1c %)

  6 month

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dental patients will be recruited in a consecutive manner from the clinic of the department of Oral Medicine and Periodontology, Faculty of Dentistry -Cairo University. Medical history and dental history will be taken; thorough oral examination will be done. The aim of the study will be explained to the patient and the patient's acceptance to participate in the survey will be received. Non-respondent patients or patients refusing to participate will be reported with the cause of their refusal. Conventional oral and periodontal examination will be held on a dental unit using the light of the unit, mirror and probe

You may qualify if:

• For periodontitis stage III and IV patients according to (Papapanou et al., 2018 and Tonetti et al., 2018)
• Bleeding on probing (BOP) ≥ 30%.
• At least four non-adjacent teeth sites in each jaw having CAL ≥ 5 mm and PD ≥ 6 mm in one or more sites.
• Tooth loss due to periodontitis ≥ 5 teeth.
• Presence of a minimum of 15 natural teeth. For diabetes and non-diabetic patients according to ("Diagnosis and Classification of Diabetes Mellitus," 2014)
• 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%.
• 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.

You may not qualify if:

• Individuals with any known systemic disease other than type 2 diabetes.
• Pregnant and lactating women.
• Individuals that received periodontal treatment within the last 6 months.
• Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.
• Former or current smokers.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university Faculty of dentistry

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Asmaa samir, master

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa Samir, Master

CONTACT

01000797021; Asmaaabdelfatah@dentistry.cu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asmaa Samir

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

EG (1)