Association Between Apical Periodontitis and Psoriasis Vulgaris

Apical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06436339
• Other study ID #: PSY003
• Status: Completed
• Start date: February 2, 2022
• Est. completion date: November 25, 2023

Study information

• Verified date: May 2024
• Source: University of Siena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: November 25, 2023
• Est. primary completion date: November 25, 2023
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Apical Periodontitis
• Periapical Periodontitis
• Periodontitis
• Psoriasis

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Senese	Siena	Toscana

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	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	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
Primary	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	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