Clinical trial NCT05792787: Association Between Apical Periodontitis and Atherosclerotic Cardiovascular Diseases
Official title: Association Between Apical Periodontitis and Atherosclerotic Cardiovascular Diseases: a Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apical Periodontitis
Atherosclerotic Cardiovascular Disease
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 65
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
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.

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.

Detailed description: The aim of the present case-control study is to evaluate the multiplicative effect of AP on secondary outcomes of ASCVD. Sixty-two subjects will be enrolled from the Unit of Endodontics and Restorative dentistry of the university of Siena.

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 will be excluded from this study.

The atherosclerosis risk factors excluded in our study are prior or existing signs of CVD, smoking habits, diabetes, obesity, arterial hypertension, dyslipidemia, and echocardiographically detectable left ventricular hypertrophy. Patients with periodontal disease and lesions other than endodontic etiology in maxilla/mandible are also excluded from this study. Participants that were pregnant or lactating females, non-Italian, or only English-speaking are also excluded from the study, as well as those who were unable or unwilling to give informed consent.

Sixty-two subjects fulfilling the previously described criteria will be enrolled from the outpatient department and allocated into two 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 individuals (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 those patients with at least one tooth exhibiting radiographic evidence of apical radiolucency exceedingly twice the width of the periodontal ligament space. A complete dental examination will be performed on each patient in both groups.

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 measurements will be recorded by one endodontist (GM). All individuals will undergo 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 where carotid intima-media thickness (cIMT), presence of abdominal aortic aneurysm, presence of peripheral pulses through echo-color-doppler will b assessed.

The results expected from this study are:

* a significant increase in ASCVD secondary parameters (outcomes) in patients with PA (exposure factor), compared with subjects without PA;
* significant association between BP and the presence of peripheral pulses and abdominal aortic aneurysm, respectively.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Carotid Intima medial Thickness (c-IMT)
timeFrame: 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
measure: Presence of Carotid Plaque
timeFrame: 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:
measure: North American Symptomatic Carotid Endarterectomy Trial (NASCET)
timeFrame: 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
measure: Ankle Brachial Index (ABI)
timeFrame: 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
measure: Right and Left Common Iliac Arteries (CIA) diameter
timeFrame: 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
measure: Abdominal aorta maximum diameter
timeFrame: 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
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
Study officials:
affiliation: University of Siena
name: Simone Grandini, PhD, DDS
role: PRINCIPAL_INVESTIGATOR
References: