Apical PeriodontitisNCT06436339
Association Between Apical Periodontitis and Psoriasis Vulgaris
An observational study of Apical Periodontitis, run by University of Siena at 1 site in Italy.
Trial summary
The aim of the present cross-sectional study is to assess the presence of AP and caries in psoriasis vulgaris individuals and to examine whether these medications influence these oral conditions. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Apical Periodontitis
- How many people
- 152 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2022to 25 Nov 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Participants were recruited from a specialty outpatient dermatology clinic (Unit of Dermatology, Azienda Ospedaliero-Universitaria Senese, Siena, Italy) from February 2022 to November 2023. Patients were eligible based on the inclusion criteria. Individuals were included in the study after they read and signed the written informed consent, in accordance with the Declaration of Helsinki.
Who may be able to join
- Age between 18 and 70
- Ability and willingness to give written consent;
- Presence of at least 6 teeth.
- Diagnosis of Psoriasis Vulgaris
- Other systemic diseases apart from psoriasis
Who cannot join
- diagnosis of periodontitis
- inability or unwillingness to give informed consent;
- periodontal treatment within the previous 6 months;
- ongoing immunosuppressive treatments or antibiotic therapy for other systemic diseases;
- pregnant or on lactation;
- additional comorbidities
- non endodontic lesions in maxilla/mandible;
- AP diagnosed on teeth with inadequate endodontic treatments and coronal restorations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Apical Periodontitis and Psoriasis Vulgaris: a Cross-sectional Study
The aim of the present cross-sectional study is to assess the presence of AP and caries in psoriasis vulgaris individuals and to examine whether these medications influence these oral conditions. Therefore, 154 patients diagnosed with psoriasis were included in the study and subjected to oral examination to assess for presence of periapical lesions and caries experience.
Read the detailed description
The aim of the study is to evaluate the prevalence of apical periodontitis (AP) and caries in subjects with psoriasis vulgaris. 152 patients with psoriasis vulgaris were included in the study. The severity and extent of psoriasis were assessed according to The Psoriasis Area Severity Index (PASI), the Body Surface Area (BSA), and the Physician's Global Assessment Scale (PGA). Periapical status was assessed through dental examination and periapical radiographs. Data regarding Periapical Index (PAI), caries experience expressed as the Decayed, Missing, Filled Teeth Index (DMFT), and psoriasis medications were recorded. A predictive logistic regression model for the presence of AP and a linear regression model were then built to relate the severity and extent of AP to the type of drug therapy taken for psoriasis and to the severity and extent of the skin disease.
- Conditions
- Apical Periodontitis
- Keywords
- Psoriasis vulgaris
- Medical subject headings
- Periapical Periodontitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Apical Periodontitis
The periapical status was investigated by palpation, percussion, thermal cold testing, and panoramic radiographs. Afterward, teeth that exhibited deep carious lesions, deep restorations, no response to pulp testing, or painful response to biting and/or percussion or palpation were suspected of AP. Those teeth underwent further periapical radiograph using the long cone paralleling technique with a film holder. AP cases were diagnosed based on the identification of at least one tooth with periapical radiolucency outpacing twice the width of the periodontal ligament space and having PAI > 2.
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
Periapical Index Score (PAI)
Periapical health was assessed radiographically using the PAI score that was determined through visual inspection of the periapical area, assigning a numerical value based on the extent and severity of inflammation. Scores ranged from 0 to 5
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
The DMFT index is calculated by summing the scores for decayed (D), missing (M), and filled (F) teeth for an individual or a group of individuals
The DMFT index is calculated by summing the scores for decayed (D), missing (M), and filled (F) teeth for an individual or a group of individuals
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 May 2024
- Study start2 Feb 2022
- Primary completion25 Nov 2023
- Study completion25 Nov 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 152 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436339
- Sponsor's protocol ID
- PSY003
- Status last verified
- May 2024
- First submitted
- 23 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Apical Periodontitis and Psoriasis Vulgaris: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06436339
- Acronym / sponsor ID
- PSY003
- Conditions
- Apical Periodontitis
- Keywords
- Psoriasis vulgaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 25 Nov 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 31 May 2024 (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 present cross-sectional study is to assess the presence of AP and caries in psoriasis vulgaris individuals and to examine whether these medications influence these oral conditions. Therefore, 154 patients diagnosed with psoriasis were included in the study and subjected to oral examination to assess for presence of periapical lesions and caries experience.
Detailed description
The aim of the study is to evaluate the prevalence of apical periodontitis (AP) and caries in subjects with psoriasis vulgaris. 152 patients with psoriasis vulgaris were included in the study. The severity and extent of psoriasis were assessed according to The Psoriasis Area Severity Index (PASI), the Body Surface Area (BSA), and the Physician's Global Assessment Scale (PGA). Periapical status was assessed through dental examination and periapical radiographs. Data regarding Periapical Index (PAI), caries experience expressed as the Decayed, Missing, Filled Teeth Index (DMFT), and psoriasis medications were recorded. A predictive logistic regression model for the presence of AP and a linear regression model were then built to relate the severity and extent of AP to the type of drug therapy taken for psoriasis and to the severity and extent of the skin disease.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants were recruited from a specialty outpatient dermatology clinic (Unit of Dermatology, Azienda Ospedaliero-Universitaria Senese, Siena, Italy) from February 2022 to November 2023. Patients were eligible based on the inclusion criteria. Individuals were included in the study after they read and signed the written informed consent, in accordance with the Declaration of Helsinki.
Key inclusion criteria (5 listed)
- Age between 18 and 70
- Ability and willingness to give written consent;
- Presence of at least 6 teeth.
- Diagnosis of Psoriasis Vulgaris
- Other systemic diseases apart from psoriasis
Key exclusion criteria (8 listed)
- diagnosis of periodontitis
- inability or unwillingness to give informed consent;
- periodontal treatment within the previous 6 months;
- ongoing immunosuppressive treatments or antibiotic therapy for other systemic diseases;
- pregnant or on lactation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Apical Periodontitis
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 periapical status was investigated by palpation, percussion, thermal cold testing, and panoramic radiographs. Afterward, teeth that exhibited deep carious lesions, deep restorations, no response to pulp testing, or painful response to biting and/or percussion or palpation were suspected of AP. Those teeth underwent further periapical radiograph using the long cone paralleling technique with a film holder. AP cases were diagnosed based on the identification of at least one tooth with periapical radiolucency outpacing twice the width of the periodontal ligament space and having PAI > 2.
Periapical Index Score (PAI)
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
Periapical health was assessed radiographically using the PAI score that was determined through visual inspection of the periapical area, assigning a numerical value based on the extent and severity of inflammation. Scores ranged from 0 to 5
The DMFT index is calculated by summing the scores for decayed (D), missing (M), and filled (F) teeth for an individual or a group of individuals
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 DMFT index is calculated by summing the scores for decayed (D), missing (M), and filled (F) teeth for an individual or a group of individuals
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 3 Jun 2024.
- Individual participant dataSharing planned: Undecided. no plan to share IPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 5 inclusion and 8 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 3 Jun 2024. 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?
Apical Periodontitis (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 3 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 3 Jun 2024.