Association Between Apical Periodontitis and Atherosclerotic Cardiovascular Diseases

NCT05792787 | Completed

• 1 other identifier: CVD001
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the association between apical periodontitis (AP) and atherosclerotic cardiovascular disease (ASCVD) by assessing the multiplicative effect of AP on secondary outcomes of ASCVD. Sixty-two subjects will be enrolled from the Unit of Endodontics and Restorative dentistry and allocated into 2 distinct groups depending on the presence or absence of periapical lesions. Group 1 will be composed of 31 patients with radiographic signs of AP. On the contrary, another 31 healthy individual (free from clinical and radiographic evidence of AP) meeting the inclusion and exclusion criteria were included as controls (group 2) A complete dental examination will performed on each patient in both groups. All the patients will be subjected to a cardiovascular examination to assess carotid intima-media thickness (cIMT), presence of abdominal aortic aneurysm, presence of peripheral pulses through echo-color-doppler.

Conditions

Apical Periodontitis; Atherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• Carotid Intima medial Thickness (c-IMT)

  C-IMT measurements are done in mm, and they are taken from the right and left common carotid artery (CCA) and they are used as surrogate endpoints to diagnose early signs of carotid atherosclerotic cardiovascular diseases.

  The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point

• Presence of Carotid Plaque

  the presence of atherosclerotic plaques is considered as a surrogate endpoint point variable to diagnose early alterations of carotid atherosclerotic cardiovascular disease. Plaque is defined as a focal structure that encroaches into the arterial lumen of at least 0.5 mm or 50% of the surrounding IMT value or demonstrates a thickness \>1.5 mm as measured from the media-adventitia interface to the intima-lumen interface.

  The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point

Secondary Outcomes (4)

• North American Symptomatic Carotid Endarterectomy Trial (NASCET)

  The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point

• Ankle Brachial Index (ABI)

  The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point

• Right and Left Common Iliac Arteries (CIA) diameter

  The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point

• Abdominal aorta maximum diameter

  The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point

Study Arms (2)

Apical Periodontitis

Patients with radiographic signs of Apical Periodontitis. The inclusion criteria of the study are healthy patients older than 40 years old, the presence of at least 24 teeth and the ability and willingness to give informed consent. Participants affected by any systemic disease or being administered either antibiotics in the last 6 months or antiaggregant, antiplatelet and antihypertensive medications are excluded from this study. The atherosclerosis risk factors excluded in our study are signs of CVD, smoking habits, diabetes , obesity, arterial hypertension, dyslipidemia. Patients with periodontal disease and lesions other than endodontic etiology in maxilla/mandible will be also excluded from this study ). Participants that were pregnant or lactating females, non-Italian or only English speaking will also also excluded from the study, as well as those who were unable or unwilling to give informed consent.

Diagnostic Test: Echo-color-doppler

Control

healthy individual free from clinical and radiographic evidence of AP. The inclusion criteria of the study are healthy patients older than 40 years old, the presence of at least 24 teeth and the ability and willingness to give informed consent. Participants affected by any systemic disease or being administered either antibiotics in the last 6 months or antiaggregant, antiplatelet and antihypertensive medications are excluded from this study. The atherosclerosis risk factors excluded in our study are signs of CVD, smoking habits, diabetes , obesity, arterial hypertension, dyslipidemia. Patients with periodontal disease and lesions other than endodontic etiology in maxilla/mandible will be also excluded from this study ). Participants that were pregnant or lactating females, non-Italian or only English speaking will also also excluded from the study, as well as those who were unable or unwilling to give informed consent.

Diagnostic Test: Echo-color-doppler

Interventions

Echo-color-doppler DIAGNOSTIC_TEST

To perform the initial screening patients will undergo panoramic radiography and clinical examination followed by periapical radiographs of the teeth suspected of AP using the long cone paralleling technique with a film holder. The following parameters will be recorded: 1. The number of decayed, missing and filled teeth (DMFT index) 2. The number of teeth with AP 3. Periapical Index Score All individuals will undergo a cardiovascular examination in the Unit of Vascular Surgery, University of Siena (Siena, Italy). The cardiovascular assessment included physical examination, blood pressure measurement, past medical history and echo-color-doppler for the assessment of carotid intima-media thickness (cIMT), presence of abdominal aortic aneurysm and presence of peripheral pulses.

Also known as: Cardiovascular Examination

Apical Periodontitis; Control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sixty-two subjects fulfilling the previously described criteria will be allocated into 2 distinct groups depending on the presence or absence of periapical lesions. Group 1 will be composed of 31 patients with radiographic signs of AP. On the contrary, another 31 healthy individual (free from clinical and radiographic evidence of AP) meeting the inclusion and exclusion criteria will be included as controls (group 2) and matched on age, BMI, sex and physical characteristics. AP cases will be designated as those patients with at least 1 tooth exhibiting radiographic evidence of apical radiolucency exceedingly twice the width of the periodontal ligament space.

You may qualify if:

• patients older than 40 years old
• the presence of at least 24 teeth
• the ability and willingness to give informed consent

You may not qualify if:

• any systemic diseases
• antibiotic administration in the last 6 months
• antiaggregant, antiplatelet and antihypertensive medications
• existing signs of CVD
• smoking habits, diabetes
• obesity
• arterial hypertension
• dyslipidemia
• periodontal disease
• lesions other than endodontic etiology in maxilla/mandible were also excluded from this study
• pregnant or lactating females non-Italian or only English speaking
• inability or unwillingness to give informed consent.

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Periapical Periodontitis; Atherosclerosis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Simone Grandini, PhD, DDS

  University of Siena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 31, 2023
• Study Start: September 20, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

IT (1)