Impact of Non-surgical Periodontal Therapy in the Management of Plaque Psoriasis.

Psoriasis Clinical Trial

Official title:

Impact of Non-surgical Periodontal Therapy in the Management of Plaque Psoriasis. A Randomised Controlled Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05311501
• Other study ID #: TPSO001
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: June 2022
• Source: University of Siena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Both periodontitis and plaque psoriasis are non communicable chronic inflammatory diseases. They share genetic polymorphysms (IL-1, IL-6 e TNFalfa) and risk factors (smoking, diabetes, obesity), as well as a great resemblance in terms of pathophysiological pathways. In fact, they are both characterized by an hyperactivation of the innate immune response which induces an excessive production of cytokines such as IL-17/TNFalfa. While non-surgical periodontal therapy consists in the mechanical removal of supra and subgingival calculus, psoriasis treatment involves the administration of either systemic or biologic drugs. Evidence is scarce regarding the effectiveness of non-surgical periodontal therapy in ameliorating the clinical outcomes of plaque psoriasis. The biological plausibility relies on the important reduction of systemic inflammation caused by periodontal treatment, which could ameliorate psoriasis phenotype.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• diagnosis of plaque psoriasis;

• diagnosis of untreated periodontitis;

• presence of at least 20 teeth;

• age between 18 and 70 years;

• ability and willingness to give informed consent.

Exclusion Criteria:

• inability of unwillingness to give informed consent;

• patients undergoing periodontal treatment within the last 6 months;

• patients undergoing immunosuppressive treatments for other systemic diseases;

• pregnancy or lactation;

• pts undergoing antibiotic therapy.

Related Conditions & MeSH terms

• Periodontitis
• Psoriasis
• Psoriasis Vulgaris

Intervention

Other:
• Non-surgical periodontal treatment
Non-Surgical periodontal Treatment was performed by removing supra and subgingival calculus and using both ultrasonic and manual instruments. Oral Hygiene Instructions (OHI) were provided throughout the experimental period. Local anesthesia was performed only when needed.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Senese	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Salivary Concentration of miRNAs- Baseline	The salivary concentration of specific miRNAS involved in both psoriasis and periodontitis (miRNA146a, miRNA223, miRNA21, miRNA155) was detected. The higher the concentration, the worse the severity of both periodontitis and psoriasis.	Salivary Concentration of miRNAs was registered at baseline.
Other	Salivary Concentration of miRNAs- 10 weeks	The salivary concentration of specific miRNAS involved in both psoriasis and periodontitis (miRNA146a, miRNA223, miRNA21, miRNA155) was detected. The higher the concentration, the worse the severity of both periodontitis and psoriasis.	Salivary Concentration of miRNAs was registered 10 weeks after baseline.
Primary	PASI (Psoriasis Area and Severity Index)- Baseline	A representative area of psoriasis is selected for each body region (head and neck, upper and lower limbs, trunk). The intensity of redness, thickness, and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3), or very severe (4). The three intensity scores are added up for each of the four body regions to give subtotals A1, A2, A3, A4.; Each subtotal is multiplied by the body surface area represented by that region. The higher the score, the worse psoriasis severity.	PASI was registered at baseline.
Primary	PASI (Psoriasis Area and Severity Index)- 10 weeks	A representative area of psoriasis is selected for each body region (head and neck, upper and lower limbs, trunk). The intensity of redness, thickness, and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3), or very severe (4). The three intensity scores are added up for each of the four body regions to give subtotals A1, A2, A3, A4.; Each subtotal is multiplied by the body surface area represented by that region. The higher the score, the worse psoriasis severity.	PASI was registered 10 weeks after baseline.
Secondary	Body Surface Area (BSA)- Baseline	BSA is calculated as the extent to which the body is affected by psoriasis. The score ranges between 0 and 100; the higher the score, the worse psoriasis severity.	BSA was registered at baseline.
Secondary	Body Surface Area (BSA)- 10 weeks	BSA is calculated as the extent to which the body is affected by psoriasis. The score ranges between 0 and 100; the higher the score, the worse psoriasis severity.	BSA was registered 10 weeks after baseline.