Prevalence of Periodontitis in Patients With Plaque Psoriasis. A Cross-sectional Study

NCT ID: NCT04722094

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 147 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2021-08-25

Brief Summary

Psoriasis is a chronic inflammatory disease with a multi-factorial etiology which affects the epidermis and dermis. It affects around 1-3% of the general population and its most frequent form is plaque psoriasis (around 80-90% of the overall psoriasis cases). Psoriasis severity and extension are usually measured through 2 scores: Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA). Periodontitis is a chronic inflammatory disease mediated by the biofilm and with a multi-factorial etiology. Its manifestation entails the destruction of the periodontal tissues surrounding the teeth; the final stage of disease is characterised by tooth loss. Periodontitis severity and extension are usually evaluated through surrogate variables such as: BoP (Bleeding on Probing), PPD (Probing Pocket Depth) e REC (Recession). Both diseases present overlapping genetic and pathophysiologic features, as well as common risk factors (e.g. genetic polymorphisms, smoking habit, obesity, diabetes etc.).

miRNAs are small non-coding molecules involved in the regulation of various biologic processes thanks to their interaction with mRNAs. Active inflammatory processes either in the oral cavity or at a systemic level tend to alter the concentration of salivary miRNAs. No study so far has ever profiled the levels of specific salivary miRNAs in patients with psoriasis and periodontitis.

Some case-control studies highlighted a higher prevalence of periodontitis in patients with psoriasis when compared to healthy controls. Nonetheless, epidemiological data regarding periodontitis prevalence in patients with psoriasis are lacking; moreover, few data are available regarding the relationship between the severity of psoriasis and the severity of periodontitis, together with the effect of common risk factors (e.g. diet, obesity, physical activity, sleep quality etc.).

Conditions

Psoriasis; Plaque Psoriasis; Periodontal Diseases; Periodontitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with Psoriasis

All patients pertaining to the Unit of Dermatology and affected by psoriasis will be screened for the inclusion in the study

Full periodontal chart

Intervention Type: DIAGNOSTIC_TEST

A full periodontal chart will be carried out including all biometric periodontal variables: Probing Pocket Depth (PPD), Bleeding on Probing (BoP), presence of Plaque, recession (REC), Full Mouth Plaque Score (FMPS), Full Mouth Bleeding Score (FMBS), presence of furcation and mobility. Periodontal status, as assessed by the periodontal chart, will be evaluated following the New Classification of Periodontal and Peri implant diseases.

Saliva sampling

Intervention Type: OTHER

Saliva samples for miRNAs detection will be taken before starting the visit.

Interventions

Full periodontal chart

A full periodontal chart will be carried out including all biometric periodontal variables: Probing Pocket Depth (PPD), Bleeding on Probing (BoP), presence of Plaque, recession (REC), Full Mouth Plaque Score (FMPS), Full Mouth Bleeding Score (FMBS), presence of furcation and mobility. Periodontal status, as assessed by the periodontal chart, will be evaluated following the New Classification of Periodontal and Peri implant diseases.

Intervention Type: DIAGNOSTIC_TEST

Saliva sampling

Saliva samples for miRNAs detection will be taken before starting the visit.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 70 years old
• Diagnosis of plaque psoriasis
• Ability and willingness to give informed consent

Exclusion Criteria

• Inability of unwillingness to give informed consent
• Pregnancy or lactation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Siena

OTHER

Sponsor Role: lead

Responsible Party

Nicola Discepoli

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicola Discepoli, DDS, MsC, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Siena

Locations

AOUS

Siena, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Nicola Discepoli, DDS, MsC, PhD

Role: CONTACT

nicola.discepoli2@unisi.it

0577 585772

Facility Contacts

Nicola Discepoli

Role: primary

ndiscepoli@me.com

Other Identifiers

PSO001

Identifier Type: -

Identifier Source: org_study_id