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GCF miRNA-223 , -214 Levels in Smokers and Nonsmokers Periodontitis Patients

Sponsor
Fayoum University (Other)
Overall Status
Completed
CT.gov ID
NCT06064799
Collaborator
(none)
42
Enrollment
1
Location
5.9
Actual Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective: Periodontitis is a multifactorial disease that affects a wide range of populations. However, its pathogenesis remains unclear. miRNAs are now considered potential diagnostic markers for many inflammatory diseases. Thus, the aim of this study was to assess the expression of microRNA-223(miRNA-223) and microRNA-214 (miRNA-214) in gingival crevicular fluid (GCF) of smoker and nonsmoker with periodontitis.

Materials and Methods: We conducted a prospective study among 42 participants: 14 healthy controls, 14 nonsmoker periodontitis participants, and 14 smoker with periodontitis. Eligibility criteria for inclusion were consecutive adults, aged 20-60 years, with stage III periodontitis grade B/C and no systemic diseases. All consenting participants had gingival crevicular fluid samples collected after diagnosis to assess miRNA-214 and -223 by quantitative real-time polymerase chain reaction assay.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: miRNA-223 & -214 detection

Study Design

Study Type:
Observational
Actual Enrollment :
42 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Expression of microRNA-223 and microRNA-214 in Gingival Crevicular Fluid of Smoker and Nonsmoker Periodontitis Patients, an Observational Diagnostic Accuracy Study
Actual Study Start Date :
Jan 1, 2023
Actual Primary Completion Date :
Jun 30, 2023
Actual Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Group I

14 healthy volunteers

Diagnostic Test: miRNA-223 & -214 detection
miRNA-223 & -214 detection in GCF samples by PCR kits
Group II

14 periodontitis participants with stage III grade B Periodontitis

Diagnostic Test: miRNA-223 & -214 detection
miRNA-223 & -214 detection in GCF samples by PCR kits
Group III

14 periodontitis participants with stage III grade C Periodontitis

Diagnostic Test: miRNA-223 & -214 detection
miRNA-223 & -214 detection in GCF samples by PCR kits

Outcome Measures

Primary Outcome Measures

  1. assessment of miRNA-223 & -214 levels in GCF samples in all groups [level of miR-223 & -214 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]

    PCR kits are used for assessment of miRNA-223 & -214 levels in GCF samples in all groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • both genders

  • age from 20 to 60 years

  • no more than 4 teeth lost due to periodontitis

  • systemically free participants

Exclusion Criteria:

  • Pregnant or lactating female

  • participants with a history of an inflammatory or immunological disease

  • history of any current medication

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:
NCT06064799
Other Study ID Numbers:
  • REC-FDBSU/05012023-04/AM
First Posted:
Oct 3, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nayroz Tarrad, associate professor, Fayoum University
Periodontitis
microRNA
smoking
GCF
biofluids
Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis

Study Results

No Results Posted as of Oct 3, 2023