Clinical trial NCT04930588: Levels of Neuregulin-4 and Its Receptor ErbB4 in Periodontitis Patients With and Without Diabetes Type 2
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Diabetes Mellitus
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.

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.

Primary outcomes:
measure: Neuregulin-4 in the GCF
timeFrame: 6 month
measure: The receptor ErbB4 in the GCF
timeFrame: 6 month
measure: Neuregulin-4 in the saliva
timeFrame: 6 month
measure: The receptor ErbB4 in saliva
timeFrame: 6 month
Secondary outcomes:
measure: Pocket depth
timeFrame: 6 month
measure: Clinical attachment level
timeFrame: 6 month
measure: Bleeding on probing
timeFrame: 6 month
measure: plaque index
timeFrame: 6 month
measure: Glycosylated Haemoglobin (HbA1c %)
timeFrame: 6 month
measure: Fasting plasma Glucose Level (FPG)
timeFrame: 6 month
measure: Body Mass Index (BMI)
timeFrame: 6 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university Faculty of dentistry
Study officials:
affiliation: Cairo University
name: Asmaa samir, master
role: PRINCIPAL_INVESTIGATOR
References: