NCT06436339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

1.8 years

First QC Date

May 23, 2024

Last Update Submit

May 30, 2024

Conditions

Keywords

Psoriasis vulgaris

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Universitaria Senese

Siena, Tuscany, 53100, Italy

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Endodontics, Periodontology, Restorative and Paediatric Dentistry

Study Record Dates

First Submitted

May 23, 2024

First Posted

May 31, 2024

Study Start

February 2, 2022

Primary Completion

November 25, 2023

Study Completion

November 25, 2023

Last Updated

June 3, 2024

Record last verified: 2024-05

Locations