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

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ClinicalTrials.gov Identifier: NCT04824209
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
University of Turin, Italy

Study Description
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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/diabetes status.


Condition or disease
Apical Periodontitis Insulin Resistance PreDiabetes Diabetes; Stable

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. The study has been designed to assess the serum level of lipopolysaccharide-binding protein (LBP), TNF-α, IL-1β, IL-6, IL-8 and the platelet factor 4 (PF4) by ELISA assay. PF4 will be dosed also in platelets.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 25 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Evaluation of Serum Markers of Pro-diabetes Inflammation in Patients With Chronic Apical Periodontitis Before and After Endodontic Treatment.
Actual Study Start Date : February 9, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : February 28, 2022
Groups and Cohorts
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Group/Cohort
AP group
Healthy patients between 25-55 years with Apical Periodontitis
Control Group
Healthy patients between 25-55 years without Apical Periodontitis


Outcome Measures
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Primary Outcome Measures :
  1. Variation in pro-diabetes inflammation markers over time upon endodontic intervention. [ Time Frame: Baseline serum levels of selected pro-diabetes inflammation markers in control group and AP group. ]
    Dosage of Lipopolysaccharide Binding Protein (LPB) (µg/mL), TNF-α, IL-1β, IL-6, IL-8 (pg/mL) and platelet factor 4 (PF4) (ng/mL) in serum and PF4 in platelets (ng/10^6 platelets) by ELISA assay.

  2. Variation in pro-diabetes inflammation markers over time upon endodontic intervention. [ Time Frame: Serum levels of selected pro-diabetes inflammation markers at 6 months after endodontic treatment and in control group. ]
    Dosage of Lipopolysaccharide Binding Protein (LPB) (µg/mL), TNF-α, IL-1β, IL-6, IL-8 (pg/mL) and platelet factor 4 (PF4) (ng/mL) in serum and PF4 in platelets (ng/10^6 platelets) by ELISA assay.

  3. Variation in pro-diabetes inflammation markers over time upon endodontic intervention. [ Time Frame: Serum levels of selected pro-diabetes inflammation markers at 12 months after endodontic treatment and in control group. ]
    Dosage of Lipopolysaccharide Binding Protein (LPB) (µg/mL), TNF-α, IL-1β, IL-6, IL-8 (pg/mL) and platelet factor 4 (PF4) (ng/mL) in serum and PF4 in platelets (ng/10^6 platelets) by ELISA assay.


Biospecimen Retention:   Samples Without DNA
Blood Sample

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Dental Hospital
Criteria

Inclusion Criteria:

  • 25-55 years, healthy

Exclusion Criteria:

  • over 55 years, with systemic diseases
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04824209


Contacts
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Contact: Damiano Pasqualini, DDS Ass Prof +39 011670 ext 1569 damiano.pasqualni@unito.it

Locations
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Italy
Department of Oncology - University of Turin Active, not recruiting
Turin, Italy, 10126
Endodontics, Department of Surgical Sciences - Univeristy of Turin Recruiting
Turin, Italy, 10126
Contact: Damiano Pasqualini, DDS Ass Prof    +39 011670 ext 1569    damiano.pasqualini@unito.it   
Contact    +39 335451070    damiano.pasqualini@unito.it   
Sponsors and Collaborators
University of Turin, Italy
Investigators
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Principal Investigator: Damiano Pasqualini, DDS Ass Pro Endodontics, Department of Surgical Sciences - Univeristy of Turin
More Information
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Responsible Party: University of Turin, Italy
ClinicalTrials.gov Identifier: NCT04824209    
Other Study ID Numbers: 0094485
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Turin, Italy:
Endodontics
Apical Periodontitis
Insulin Resistance
Diabetes
Pro-Diabetes Inflammation Markers
Additional relevant MeSH terms:
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Diabetes Mellitus
Periodontitis
Periapical Periodontitis
Insulin Resistance
Inflammation
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pathologic Processes
Hyperinsulinism
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periapical Diseases
Jaw Diseases