Apical PeriodontitisNCT05792787
Association Between Apical Periodontitis and Atherosclerotic Cardiovascular Diseases
An observational study of Apical Periodontitis and Atherosclerotic Cardiovascular Disease, run by University of Siena at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Apical Periodontitis, Atherosclerotic Cardiovascular Disease
- What is being tested?
- Echo-color-doppler
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 20 Sep 2022to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients older than 40 years old
- the presence of at least 24 teeth
- the ability and willingness to give informed consent
Who cannot join
- any systemic diseases
- antibiotic administration in the last 6 months
- antiaggregant, antiplatelet and antihypertensive medications
- existing signs of CVD
- smoking habits, diabetes
- obesity
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Apical Periodontitis and Atherosclerotic Cardiovascular Diseases: a Case-control Study
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.
Read the 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:
- The number of decayed, missing, and filled teeth (DMFT index)
- The number of teeth with AP
- 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.
- Being tested
- Echo-color-doppler
- Medical subject headings
- Periapical Periodontitis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echo-color-dopplerDiagnostic test
Also called Cardiovascular Examination
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:
- The number of decayed, missing and filled teeth (DMFT index)
- The number of teeth with AP
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Echo-color-doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 NASCET method is used to calculate the percentage of stenosis in carotid arteries. The NASCET percentage is the ratio between the residual diameter at the stenosis and the surface of the distal normal lumen where there is no stenosis subtracted by the residual diameter at the stenosis.
Measured: 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 ankle-brachial index (ABI) is a non-invasive tool for the assessment of vascular status. It consists of the ratio between the systolic blood pressure of the lower extremity (i.e., the ankle) and the upper extremity.
Measured: 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
Measuring the diameter of the CIAs (mm) can be done to assess for potential conditions such as peripheral artery disease (PAD) or an abdominal aortic aneurysm (AAA
Measured: 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
Measuring the diameter of the abdominal aorta (mm) can be done to assess for potential abdominal aortic aneurism.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start20 Sep 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Grandini, University of Siena
- Investigators
- Simone Grandini, PhD, DDS, Principal investigator, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792787
- Sponsor's protocol ID
- CVD001
- Status last verified
- Nov 2023
- First submitted
- 16 Feb 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Apical Periodontitis and Atherosclerotic Cardiovascular Diseases: a Case-control Study
- ClinicalTrials.gov ID
- NCT05792787
- Acronym / sponsor ID
- CVD001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The number of decayed, missing, and filled teeth (DMFT index)
- The number of teeth with AP
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apical Periodontitis | – | Diagnostic Test: Echo-color-dopplerPatients 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. |
| Control | – | Diagnostic Test: Echo-color-dopplerhealthy 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- patients older than 40 years old
- the presence of at least 24 teeth
- the ability and willingness to give informed consent
Key exclusion criteria (12 listed)
- any systemic diseases
- antibiotic administration in the last 6 months
- antiaggregant, antiplatelet and antihypertensive medications
- existing signs of CVD
- smoking habits, diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echo-color-dopplerAlso: Cardiovascular ExaminationTo 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. | Diagnostic test | Apical Periodontitis, Control |
Primary outcome
Carotid Intima medial Thickness (c-IMT)
Time frame: 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
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.
Presence of Carotid Plaque
Time frame: 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
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.
4 secondary outcomes
North American Symptomatic Carotid Endarterectomy Trial (NASCET)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Necrotic Pulps With no Apical Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Grandini, PhD, DDS principal investigator
University of Siena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apical Periodontitis and Atherosclerotic Cardiovascular Disease, run by University of Siena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid Intima medial Thickness (c-IMT) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.