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

NCT ID: NCT04824209

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-09

Study Completion Date

2023-04-25

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.

Conditions

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Apical Periodontitis Insulin Resistance PreDiabetes Diabetes; Stable

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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AP group

Healthy patients between 25-55 years with Apical Periodontitis

No interventions assigned to this group

Control Group

Healthy patients between 25-55 years without Apical Periodontitis

No interventions assigned to this group

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Damiano Pasqualini, DDS Ass Pro

Role: PRINCIPAL_INVESTIGATOR

Endodontics, Department of Surgical Sciences - Univeristy of Turin

Locations

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Department of Oncology - University of Turin

Turin, , Italy

Site Status

Endodontics, Department of Surgical Sciences - Univeristy of Turin

Turin, , Italy

Site Status

Countries

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Italy

Other Identifiers

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0094485

Identifier Type: -

Identifier Source: org_study_id

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