Fetuin A Association in Periodontal Disease and Diabetes Mellitus

Sponsor

Fayoum University (Other)

Overall Status

Completed

CT.gov ID

NCT06064786

Collaborator

(none)

Enrollment

Location

1.5

Actual Duration (Months)

30.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis, Adult	Diagnostic Test: GCF levels of fetuin A and hsCRP evaluation

Study Design

Study Type:

Observational

Actual Enrollment :

45 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Aug 1, 2023

Actual Primary Completion Date :

Sep 15, 2023

Actual Study Completion Date :

Sep 15, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

GCF levels of fetuin A and hsCRP evaluation in all groups [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

both gender periodontitis stage III

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of dentistry, Fayoum university	Fayoum		Egypt

Sponsors and Collaborators

Fayoum University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nayroz Tarrad, associate professor, Fayoum University

ClinicalTrials.gov Identifier:

NCT06064786

Other Study ID Numbers:

REC-FDBSU/03082023-2/ER

First Posted:

Oct 3, 2023

Last Update Posted:

Oct 3, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Periodontitis

Chronic Periodontitis

Study Results

No Results Posted as of Oct 3, 2023