Fetuin A Association in Periodontal Disease and Diabetes Mellitus

Periodontitis, Adult Clinical Trial

Official title:

Evaluation of Fetuin-A and hsCRP Levels in Gingival Crevicular Fluid in Periodontitis Diabetic and Non-Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06064786
• Other study ID #: REC-FDBSU/03082023-2/ER
• Status: Completed
• Start date: August 1, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: September 2023
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim: The aim of the current study was to compare and correlate gingival crevicular fluid (GCF) fetuin-A levels and high sensitivity C-reactive protein (hs-CRP) levels in non-diabetic periodontitis patients and type 2 diabetic periodontitis patients with healthy subjects and revealing its possible role in diagnosis of periodontal disease. Methodology: Forty-five periodontitis stage III patients categorized into 3 groups according to whether having type II diabetes mellitus or not were compared to systemically and periodontally healthy participants in this investigation. Clinical parameters for all groups were recorded. Assessment of GCF levels of fetuin A and hs-CRP were done to all enrolled participants utilizing an enzyme linked immune-sorbent assay (ELISA) kit. Receiver operating characteristic (ROC) curve was performed to reveal sensitivity, specificity, predictive value and diagnostic accuracy of the markers used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• both gender periodontitis stage III

Exclusion Criteria:

1. Smoking,

2. Systemic diseases (except DM in group B),

3. Periodontitis patients having periodontal treatment recently (past 6 months),

4. Pregnancy, lactation, contraceptive pills,

5. Anti-inflammatory/ immunosuppressive drugs.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis
• Periodontitis, Adult

Intervention

Diagnostic Test:
• GCF levels of fetuin A and hsCRP evaluation
ELIZA kits are used for GCF levels of fetuin A and hsCRP evaluation

Locations

Country	Name	City	State
Egypt	faculty of dentistry, Fayoum university	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GCF levels of fetuin A and hsCRP evaluation in all groups	ELIZA kits	levels of fetuin A and hsCRP are measured at baseline after the completion of all GCF sample collection carried at the day of enrollment of subjects in the investigation after diagnosis confirmation