Serum Pro-Diabetes Inflammation Biomarkers in Patients With Apical Periodontitis.

April 26, 2023 updated by: University of Turin, Italy

Evaluation of Serum Markers of Pro-diabetes Inflammation in Patients With Chronic Apical Periodontitis Before and After Endodontic Treatment.

Inflammation is a common factor of chronic periodontitis and diabetes. However, to date, there is no scientific evidence supporting a causal effect of the inflammation created by apical periodontitis on the onset of insulin resistance and on metabolic derangement in the condition of pre-diabetes or diabetes.

A case control study has been designed in order to evaluate serum levels of pro-diabetes inflammation factors in a sample of healthy patients between 25 and 55 years of age, with or without apical periodontitis,before endodontic treatment and at 6 and 12 months post-treatment. The aim of the study is to evaluate any relation between the presence of chronic endodontic lesions and pro-diabetes inflammation factors that can promote the onset of insulin resistance, and whether endodontic treatment can reduce these factors, thus preventing a pro-diabetes status.

Study Overview

Status

Completed

Conditions

Detailed Description

Healthy, consenting and informed patients of both gender under 55 years of age with apical periodontitis will be enrolled as cases. Healthy, consenting and informed patients of both gender under 55 years of age without apical periodontitis will be enrolled as control subjects. The study has been designed to assess the serum level of TNF-α, IL-1β, IL-6, IL-8 by ELISA assay.

Study Type

Observational

Enrollment (Actual)

27

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
      • Turin, Italy, 10126
        • Department of Oncology - University of Turin
      • Turin, Italy, 10126
        • Endodontics, Department of Surgical Sciences - Univeristy of Turin

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

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Dental Hospital

Description

Inclusion Criteria:

  • 25-55 years, healthy

Exclusion Criteria:

  • under 25 years, over 55 years, patients with systemic or oral diseases or patients who underwent other dental treatments in the previous 6 months

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: Prospective

Cohorts and Interventions

Group / Cohort
AP group
Healthy patients between 25-55 years with Apical Periodontitis
Control Group
Healthy patients between 25-55 years without Apical Periodontitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in pro-diabetes inflammation markers over time upon endodontic intervention.
Time Frame: Baseline serum levels of selected pro-diabetes inflammation markers in control group and AP group.
Dosage of TNF-α, IL-1β, IL-6, IL-8 (pg/mL) in serum(ng/10^6 platelets) by ELISA assay.
Baseline serum levels of selected pro-diabetes inflammation markers in control group and AP group.
Variation in pro-diabetes inflammation markers over time upon endodontic intervention.
Time Frame: Serum levels of selected pro-diabetes inflammation markers at 6 months after endodontic treatment and in control group.
Dosage of TNF-α, IL-1β, IL-6, IL-8 (pg/mL) in serum by ELISA assay.
Serum levels of selected pro-diabetes inflammation markers at 6 months after endodontic treatment and in control group.
Variation in pro-diabetes inflammation markers over time upon endodontic intervention.
Time Frame: Serum levels of selected pro-diabetes inflammation markers at 12 months after endodontic treatment and in control group.
Dosage of TNF-α, IL-1β, IL-6, IL-8 (pg/mL) in serum by ELISA assay.
Serum levels of selected pro-diabetes inflammation markers at 12 months after endodontic treatment and in control group.

Collaborators and Investigators

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

Sponsor

University of Turin, Italy

Investigators

  • Principal Investigator: Damiano Pasqualini, DDS Ass Pro, Endodontics, Department of Surgical Sciences - Univeristy of Turin

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)

February 9, 2021

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 25, 2023

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0094485

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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