Fetuin A Association in Periodontal Disease and Diabetes Mellitus

NCT06064786 | Completed

• 1 other identifier: REC-FDBSU/03082023-2/ER
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis, Adult

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group I

15 healthy patients with generalized periodontitis stage III.

Diagnostic Test: GCF levels of fetuin A and hsCRP evaluation

Group II

15 patients suffering from type 2 diabetes mellitus with generalized periodontitis stage III

Diagnostic Test: GCF levels of fetuin A and hsCRP evaluation

Group III

15 systemically healthy patients without periodontitis

Diagnostic Test: GCF levels of fetuin A and hsCRP evaluation

Interventions

GCF levels of fetuin A and hsCRP evaluation DIAGNOSTIC_TEST

ELIZA kits are used for GCF levels of fetuin A and hsCRP evaluation

Group I; Group II; Group III

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

individuals recruited from outpatient clinic of periodontology department

You may qualify if:

• both gender periodontitis stage III

You may not qualify if:

• Smoking,
• Systemic diseases (except DM in group B),
• Periodontitis patients having periodontal treatment recently (past 6 months),
• Pregnancy, lactation, contraceptive pills,
• Anti-inflammatory/ immunosuppressive drugs.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

faculty of dentistry, Fayoum university

Al Fayyum, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

GCF samples

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 3, 2023
• Study Start: August 1, 2023
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)