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Completed

NCT Number: NCT04382105

Evaluation of Saliva IL-6 Levels and Periodontitis

The aim of this study was to analyze the association between salivary IL-6 levels in patients with periodontitis. Furthermore, the objective was to determine if the periodontitis influenced salivary IL-6 levels

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Messina

Messina, 98100, Italy

About this study

Forty-nine patients with periodontitis and 47 healthy subjects (HS) were enrolled in the present study. Enrolled patients were examined and characterized for clinical and blood samples analysis, and salivary IL-6 levels. The Spearman Correlation Test and Jonckheere-Terpstra Test were applied in order to assess the interdependence between salivary IL-6 levels and clinical periodontal parameters.

Who can participate

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

Inclusion criteria

  • Presence of at least 16 teeth
  • CP with a minimum of 40% of sites with a clinical attachment level (CAL)

≥2mm and probing depth (PD) ≥4mm;

  • Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
  • Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion criteria

  • Intake of contraceptives
  • Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
  • Status of pregnancy or lactation
  • Previous history of excessive drinking
  • Allergy to local anaesthetic
  • Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Treatment and study plan

Observation of salivary IL-6 levels

Other

Observation of salivary IL-6 levels and correlation of salivary IL-6 levels with periodontal disease

Primary outcomes

  1. Clinical Attachment Level

    Time frame: 1-year

    evaluation of changes in clinical attachment level

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

Association Between Salivary IL-6 and Extent of Periodontitis

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 11, 2020
Registry last updated
Nov 24, 2020

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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