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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04722094
• Other study ID #: PSO001
• Status: Recruiting
• Start date: January 25, 2021
• Est. completion date: August 25, 2021

Study information

• Verified date: February 2021
• Source: University of Siena
• Contact: Nicola Discepoli, DDS, MsC, PhD
• Phone: 0577 585772
• Email: nicola.discepoli2[@]unisi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 147
• Est. completion date: August 25, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontitis
• Plaque Psoriasis
• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
Italy	AOUS	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Periodontitis in patients with Plaque psoriasis	The prevalence of patients with a diagnosis of periodontitis among the included cohort will be measured.	Baseline
Secondary	relationship between salivary miRNAs concentration and the severity of psoriasis and periodontitis	salivary levels of miRNAs will be related to the severity of psoriasis and periodontitis	Baseline