Fetuin A Association in Periodontal Disease and Diabetes Mellitus

September 26, 2023 updated by: Nayroz Tarrad, Fayoum University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Fayoum, Egypt
        • Faculty of dentistry, Fayoum University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

individuals recruited from outpatient clinic of periodontology department

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I
15 healthy patients with generalized periodontitis stage III.
Diagnostic test: GCF levels of fetuin A and hsCRP evaluation
ELIZA kits are used for 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
ELIZA kits are used for 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
ELIZA kits are used for GCF levels of fetuin A and hsCRP evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GCF levels of fetuin A and hsCRP evaluation in all groups
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

September 15, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-FDBSU/03082023-2/ER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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