## Protocol Section
### Identification Module
**NCT ID:** NCT06436339

**Brief Title:** Association Between Apical Periodontitis and Psoriasis Vulgaris

**Official Title:** Association Between Apical Periodontitis and Psoriasis Vulgaris: a Cross-sectional Study

#### Organization Study ID Info
**ID:** PSY003
#### Organization
**Class:** OTHER
**Full Name:** University of Siena
### Status Module
#### Completion Date
**Date:** 2023-11-25

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-11-25

**Type:** ACTUAL

#### Start Date
**Date:** 2022-02-02

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Siena

#### Responsible Party

**Investigator Affiliation:** University of Siena

**Investigator Full Name:** Simone Grandini

**Investigator Title:** Prof

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Apical Periodontitis

**Keywords:**

- Psoriasis vulgaris

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 152

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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

**Description:** 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

**Measure:** 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

**Description:** 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

**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

**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

### Eligibility Module

**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

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Siena

**Country:** Italy

**Facility:** Azienda Ospedaliera Universitaria Senese

**State:** Toscana

**Zip:** 53100

### IPD Sharing Statement Module

**Description:** no plan to share IPD

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000017444

- Term: Skin Diseases, Papulosquamous

- ID: D000012871

- Term: Skin Diseases

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000010483

- Term: Periapical Diseases

- ID: D000007571

- Term: Jaw Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M13395

- Name: Periapical Periodontitis

- Relevance: HIGH

- As Found: Apical Periodontitis

- ID: M14422

- Name: Psoriasis

- Relevance: HIGH

- As Found: Psoriasis

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19713

- Name: Skin Diseases, Papulosquamous

- Relevance: LOW

- As Found: Unknown

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13393

- Name: Periapical Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10601

- Name: Jaw Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010518

- Term: Periodontitis

- ID: D000010485

- Term: Periapical Periodontitis

- ID: D000011565

- Term: Psoriasis

### Misc Info Module

- Version Holder: 2024-05-31
