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

Periodontitis, Adult Clinical Trial

Official title:

Expression of microRNA-223 and microRNA-214 in Gingival Crevicular Fluid of Smoker and Nonsmoker Periodontitis Patients, an Observational Diagnostic Accuracy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06064799
• Other study ID #: REC-FDBSU/05012023-04/AM
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: June 30, 2023

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis
• Periodontitis, Adult

Intervention

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

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