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Evaluation of Saliva IL-6 Levels and Periodontitis

Sponsor
University of Messina (Other)
Overall Status
Completed
CT.gov ID
NCT04382105
Collaborator
(none)
287
Enrollment
1
Location
46.6
Actual Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Observation of salivary IL-6 levels

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 Design

Study Type:
Observational
Actual Enrollment :
287 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Association Between Salivary IL-6 and Extent of Periodontitis
Actual Study Start Date :
Nov 8, 2015
Actual Primary Completion Date :
Sep 15, 2019
Actual Study Completion Date :
Sep 25, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Clinical Attachment Level [1-year]

    evaluation of changes in clinical attachment level

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 65 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Messina Messina Italy 98100

Sponsors and Collaborators

  • University of Messina

Investigators

  • Study Chair: Giovanni Matarese, University of Messina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gaetano Isola, DDS, PhD, Researcher, University of Messina
ClinicalTrials.gov Identifier:
NCT04382105
Other Study ID Numbers:
  • 11-1818
First Posted:
May 11, 2020
Last Update Posted:
Nov 24, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases

Study Results

No Results Posted as of Nov 24, 2020