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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04824209
• Other study ID #: 0094485
• Status: Completed
• Start date: February 9, 2021
• Est. completion date: April 25, 2023

Study information

• Verified date: April 2023
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 25, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Apical Periodontitis
• Diabetes Mellitus
• Diabetes; Stable
• Inflammation
• Insulin Resistance
• Periapical Periodontitis
• Periodontitis
• PreDiabetes

Locations

Country	Name	City	State
Italy	Department of Oncology - University of Turin	Turin
Italy	Endodontics, Department of Surgical Sciences - Univeristy of Turin	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation in pro-diabetes inflammation markers over time upon endodontic intervention.	Dosage of TNF-a, IL-1ß, 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.
Primary	Variation in pro-diabetes inflammation markers over time upon endodontic intervention.	Dosage of TNF-a, IL-1ß, 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.
Primary	Variation in pro-diabetes inflammation markers over time upon endodontic intervention.	Dosage of TNF-a, IL-1ß, 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.