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

• ClinicalTrials.gov Identifier: NCT04722094
• Recruitment Status: Recruiting
• First Posted: January 25, 2021
• Last Update Posted: February 24, 2021
• Sponsor: University of Siena
• Information provided by (Responsible Party): Nicola Discepoli, University of Siena

Study Description

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.).

Condition or disease	Intervention/treatment
Psoriasis; Plaque Psoriasis; Periodontal Diseases; Periodontitis	Diagnostic Test: Full periodontal chart; Other: Saliva sampling

Study Design

• Study Type: Observational
• Estimated Enrollment: 147 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Prevalence of Periodontitis in Patients With Plaque Psoriasis. A Cross-sectional Study
• Actual Study Start Date: January 25, 2021
• Estimated Primary Completion Date: June 25, 2021
• Estimated Study Completion Date: August 25, 2021

Groups and Cohorts

Group/Cohort

Intervention/treatment

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

Diagnostic Test: 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.; Other: Saliva sampling; Saliva samples for miRNAs detection will be taken before starting the visit.

Outcome Measures

Primary Outcome Measures :

1. Prevalence of Periodontitis in patients with Plaque psoriasis [ Time Frame: Baseline ]
   The prevalence of patients with a diagnosis of periodontitis among the included cohort will be measured.

Secondary Outcome Measures :

1. relationship between salivary miRNAs concentration and the severity of psoriasis and periodontitis [ Time Frame: Baseline ]
   salivary levels of miRNAs will be related to the severity of psoriasis and periodontitis

Biospecimen Retention:   Samples Without DNA

Saliva sample for miRNAs extraction (miRNAs 146a, 155, 223, 21)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

All patients affected by Plaque Psoriasis and meeting the inclusion criteria will be screened for the inclusion in the present study.

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

Contacts and Locations

Contacts

Contact: Nicola Discepoli, DDS, MsC, PhD; 0577 585772; nicola.discepoli2@unisi.it

Locations

Italy

AOUS; Recruiting

Siena, Italy, 53100

Contact: Nicola Discepoli ndiscepoli@me.com

Sponsors and Collaborators

University of Siena

Investigators

• Principal Investigator: Nicola Discepoli, DDS, MsC, PhD; University of Siena

More Information

• Responsible Party: Nicola Discepoli, Researcher, University of Siena
• ClinicalTrials.gov Identifier: NCT04722094
• Other Study ID Numbers: PSO001
• First Posted: January 25, 2021
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Periodontitis; Periodontal Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Mouth Diseases; Stomatognathic Diseases