Clinical trial NCT04824209: Serum Pro-Diabetes Inflammation Biomarkers in Patients With Apical Periodontitis.
Official title: Evaluation of Serum Markers of Pro-diabetes Inflammation in Patients With Chronic Apical Periodontitis Before and After Endodontic Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apical Periodontitis
Insulin Resistance
PreDiabetes
Diabetes; Stable
Keywords: Endodontics
Apical Periodontitis
Insulin Resistance
Diabetes
Pro-Diabetes Inflammation Markers
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 27
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dental Hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Variation in pro-diabetes inflammation markers over time upon endodontic intervention.
timeFrame: Baseline serum levels of selected pro-diabetes inflammation markers in control group and AP group.
measure: Variation in pro-diabetes inflammation markers over time upon endodontic intervention.
timeFrame: Serum levels of selected pro-diabetes inflammation markers at 6 months after endodontic treatment and in control group.
measure: Variation in pro-diabetes inflammation markers over time upon endodontic intervention.
timeFrame: Serum levels of selected pro-diabetes inflammation markers at 12 months after endodontic treatment and in control group.
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Department of Oncology - University of Turin
city: Turin
country: Italy
facility: Endodontics, Department of Surgical Sciences - Univeristy of Turin
Study officials:
affiliation: Endodontics, Department of Surgical Sciences - Univeristy of Turin
name: Damiano Pasqualini, DDS Ass Pro
role: PRINCIPAL_INVESTIGATOR
References: