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

NCT04824209 | Completed

• 1 other identifier: 0094485
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Apical Periodontitis; Insulin Resistance; PreDiabetes; Diabetes; Stable

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

AP group

Healthy patients between 25-55 years with Apical Periodontitis

Control Group

Healthy patients between 25-55 years without Apical Periodontitis

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Dental Hospital

You may qualify if:

• years, healthy

You may not qualify if:

• under 25 years, over 55 years, patients with systemic or oral diseases or patients who underwent other dental treatments in the previous 6 months

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (2)

Department of Oncology - University of Turin

Turin, 10126, Italy

Location

Endodontics, Department of Surgical Sciences - Univeristy of Turin

Turin, 10126, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Sample

MeSH Terms

Conditions

Periapical Periodontitis; Insulin Resistance; Prediabetic State; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Damiano Pasqualini, DDS Ass Pro

  Endodontics, Department of Surgical Sciences - Univeristy of Turin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: April 1, 2021
• Study Start: February 9, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 25, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

IT (2)