Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05792787 |
| Other study ID # |
CVD001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 20, 2022 |
| Est. completion date |
February 1, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
University of Siena |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
