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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Apical Periodontitis, Insulin Resistance, PreDiabetes, Diabetes; Stable

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AP group<br>Healthy patients between 25-55 years with Apical Periodontitis | |
| Control Group<br>Healthy patients between 25-55 years without Apical Periodontitis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in pro-diabetes inflammation markers over time upon endodontic intervention. | 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. | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endodontics, Apical Periodontitis, Insulin Resistance, Diabetes, Pro-Diabetes Inflammation Markers