Evaluation of Saliva IL-6 Levels and Periodontitis

November 23, 2020 updated by: Gaetano Isola, DDS, PhD, University of Messina

Association Between Salivary IL-6 and Extent of 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

287

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Messina, Italy, 98100
        • University of Messina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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 P.Gingivalis antibodies were expressed and evaluated enzyme-linked immunosorbent assay (ELISA) units (EU).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
observation of salivary IL-6 levels
Other: Observation of salivary IL-6 levels
Observation of salivary IL-6 levels and correlation of salivary IL-6 levels with periodontal disease
Periodontitis
observation of salivary IL-6 levels
Other: Observation of salivary IL-6 levels
Observation of salivary IL-6 levels and correlation of salivary IL-6 levels with periodontal disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Attachment Level
Time Frame: 1-year
evaluation of changes in clinical attachment level
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Messina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2015

Primary Completion (Actual)

September 15, 2019

Study Completion (Actual)

September 25, 2019

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-1818

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all collected IPD, all IPD that underlie results in a publication

IPD Sharing Time Frame

1-year

IPD Sharing Access Criteria

Official website

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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