Clinical trial NCT06436339: Association Between Apical Periodontitis and Psoriasis Vulgaris
Official title: Association Between Apical Periodontitis and Psoriasis Vulgaris: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apical Periodontitis
Keywords: Psoriasis vulgaris
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Apical Periodontitis
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: Periapical Index Score (PAI)
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: 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
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:
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
state: Toscana
Study officials:
References: