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

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.

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Key information

Conditions

Apical Periodontitis Diabetes Mellitus Diabetes; Stable Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Jaw Diseases Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis PreDiabetes Prediabetic State Stomatognathic Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Oncology - University of Turin, Turin, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.
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.
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.

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: Apr 1, 2021
Registry last updated: Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed