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Completed

NCT Number: NCT06064799

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

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.

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Key information

Conditions

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

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

faculty of dentistry, Fayoum university

Al Fayyum, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

miRNA-223 & -214 detection

Diagnostic Test

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

Primary outcomes

  1. assessment of miRNA-223 & -214 levels in GCF samples in all groups

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 3, 2023
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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