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

Completed

• Conditions: Apical Periodontitis; PreDiabetes; Diabetes; Stable; Insulin Resistance

• Registration Number: NCT04824209
• Lead Sponsor: University of Turin, Italy

Brief Summary

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.

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 Timeline

• Study Start: 2021-02-09
• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-04-01
• Primary Completion: 2022-04-30
• Status Verified: 2023-04
• Study Completion: 2023-04-25
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variation in pro-diabetes inflammation markers over time upon endodontic intervention.	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.

Trial Locations

Locations (2)

Department of Oncology - University of Turin; 🇮🇹 Turin, Italy

Endodontics, Department of Surgical Sciences - Univeristy of Turin; 🇮🇹 Turin, Italy