MedDataX Logo

Evaluation of Saliva IL-6 Levels and Periodontitis

NCT ID: NCT04382105

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

287 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-08

Study Completion Date

2019-09-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periodontal Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

observation of salivary IL-6 levels

Observation of salivary IL-6 levels

Intervention Type OTHER

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

Periodontitis

observation of salivary IL-6 levels

Observation of salivary IL-6 levels

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observation of salivary IL-6 levels

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Messina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gaetano Isola, DDS, PhD

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Giovanni Matarese

Role: STUDY_CHAIR

University of Messina

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Messina

Messina, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11-1818

Identifier Type: -

Identifier Source: org_study_id