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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04824209

Enrollment

Registered

2021-04-01

Start date

2021-02-09

Completion date

2023-04-25

Last updated

2023-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Periodontitis, Diabetes; Stable, Insulin Resistance, PreDiabetes

Keywords

Endodontics, Apical Periodontitis, Insulin Resistance, Diabetes, Pro-Diabetes Inflammation Markers

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

25 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Italy

Outcome results