- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06436339
Association Between Apical Periodontitis and Psoriasis Vulgaris
May 30, 2024 updated by: Simone Grandini, University of Siena
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
152
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Toscana
-
Siena, Toscana, Italy, 53100
- Azienda Ospedaliera Universitaria Senese
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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)
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 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
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2022
Primary Completion (Actual)
November 25, 2023
Study Completion (Actual)
November 25, 2023
Study Registration Dates
First Submitted
May 23, 2024
First Submitted That Met QC Criteria
May 23, 2024
First Posted (Actual)
May 31, 2024
Study Record Updates
Last Update Posted (Actual)
June 3, 2024
Last Update Submitted That Met QC Criteria
May 30, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSY003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
no plan to share IPD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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