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PeriodontitisNCT04930588

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

An observational study of Periodontitis and Diabetes Mellitus, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Periodontitis, Diabetes Mellitus
How many people
42 participants
Where
1 siteEgypt
Study dates
1 Jun 2021to Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Asmaa Samir, Master contact

01000797021

Asmaaabdelfatah@dentistry.cu.edu.eg

Egypt1 site, 1 recruiting

  • Cairo university Faculty of dentistry

    Cairo

    Asmaa Samir, Master, 01000797021, Asmaaabdelfatah@dentistry.cu.edu.eg

    Recruiting

Other trials in Egypt

About this study

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

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.

Read the 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.

Medical subject headings
Periodontitis, Diabetes Mellitus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neuregulin-4 in the GCF

    Measured by Enzyme-Linked Immunosorbent Assay in μL

    Measured: 6 month

  2. The receptor ErbB4 in the GCF

    Measured by Enzyme-Linked Immunosorbent Assay in μL

    Measured: 6 month

  3. Neuregulin-4 in the saliva

    Measured by Enzyme-Linked Immunosorbent Assay in μL

    Measured: 6 month

  4. The receptor ErbB4 in saliva

    Measured by Enzyme-Linked Immunosorbent Assay in μL

    Measured: 6 month

Secondary outcomes (7)

  1. Pocket depth

    Measured by Manual UNC periodontal probe in mm

    Measured: 6 month

  2. Clinical attachment level

    Measured by Manual UNC periodontal probe in mm

    Measured: 6 month

  3. 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.

    Measured: 6 month

  4. plaque index

    Measured by Manual UNC periodontal probe Scores:

    0: No plaque

    1. 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.
    2. Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye.
    3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

    Measured: 6 month

  5. Glycosylated Haemoglobin (HbA1c %)

    Measured by High performance liquid chromatography in mmol/mol

    Measured: 6 month

  6. Fasting plasma Glucose Level (FPG)

    Measured by blood sampling in (mg/dl)

    Measured: 6 month

  7. Body Mass Index (BMI)

    Measured in (Kg/m2)

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2021
  2. Study start1 Jun 2021
  3. Primary completionJun 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04930588
Sponsor's protocol ID
PER7-2-1
Status last verified
Jun 2021
First submitted
11 Jun 2021
Last updated
22 Jun 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontitis and Diabetes Mellitus, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Asmaa Samir, Master (01000797021, Asmaaabdelfatah@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neuregulin-4 in the GCF (time frame: 6 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04930588.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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