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

NCT06064799 | Completed

• 1 other identifier: REC-FDBSU/05012023-04/AM
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis, Adult

Keywords

Periodontitis; microRNA; smoking; GCF; biofluids

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group I

14 healthy volunteers

Diagnostic Test: miRNA-223 & -214 detection

Group II

14 periodontitis participants with stage III grade B Periodontitis

Diagnostic Test: miRNA-223 & -214 detection

Group III

14 periodontitis participants with stage III grade C Periodontitis

Diagnostic Test: miRNA-223 & -214 detection

Interventions

miRNA-223 & -214 detection DIAGNOSTIC_TEST

miRNA-223 \& -214 detection in GCF samples by PCR kits

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 were recruited from the outpatient clinic of the department of periodontology

You may qualify if:

• both genders
• age from 20 to 60 years
• no more than 4 teeth lost due to periodontitis
• systemically free participants

You may not qualify if:

• Pregnant or lactating female
• participants with a history of an inflammatory or immunological disease
• history of any current medication

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

faculty of dentistry, Fayoum university

Al Fayyum, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

GCF samples

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis; Smoking

Condition Hierarchy (Ancestors)

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

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: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Locations

EG (1)