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Completed

NCT Number: NCT04861493

Cathelicidin LL-37 Levels in the GCF and the Saliva of Smokers and Non-smokers With Stage III,IV Periodontitis

Periodontitis is considered an inflammatory disease that results in the disruption of oral hemeostasis and is associated with the presence of dental plaque influenced by genetic and environmental factors. It is well-establised that smokers have an increased severity of periodontal disease,a higher prevalance of tooth loss and total edentulism.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of dentistry cairo university

Al Manyal, Cairo Governorate, 11562, Egypt

About this study

Antimicrobial peptides (AMPs) are soluble molecules participating in the innate immunity of mucosal surfaces against pathogens. Dysregulated expression of AMPs has been considered a possible causal mechanistic link in the microbial dysbiosis associated with periodontal disease and some risk factors, including tobacco smoking, diabetes mellitus, and obesity.Antimicrobial peptides as a part of innate immunity are important molecules that provide a balance between disease and health. Moreover, they are considered to be an important intermediate step in initiating an initial immune response against the microbial side of the gingival epithelium and in the transition to acquired immunity. Cathelicidins, in particular - which play an important role in regulating the immunological response of oral tissues, are a group of peptides released from neutrophil granules and they are present only in humans in the form of LL-37.

Who can participate

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

Inclusion criteria

  • Presence of a minimum of 15 natural teeth.
  • At least four non-adjacent teeth sites in each jaw having CAL ≥ 5 mm and PD > 5 mm in one or more sites.
  • Bleeding on probing (BOP) ≥ 30%.
  • Tooth loss due to periodontitis ≤ 4 teeth.
  • For smoker's patients; study will include patients who regularly smoked at least 10 cigarettes/day for a minimum of 5 years.
  • For non-smokers patients; study will include patients who had never smoked.

Exclusion criteria

  • Individuals with a history of systemic diseases or immunological disorders.
  • Individuals using hormone replacement therapy.
  • Pregnant and lactating women.
  • Individuals that received periodontal treatment within the last 6 months.
  • Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.

Treatment and study plan

Primary outcomes

  1. LL-37 levels in the GCF and saliva

    Time frame: Through study completion,an average of 1 year

    GCF,Saiva sampling to assess LL-37 levels by ELISA kit.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Cathelicidin LL-37 Levels in the Gingival Crevicular Fluid and the Saliva of Smokers and Non-smokers With Stage III,IV Periodontitis :An Observational Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2021
Registry last updated
Apr 27, 2021

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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