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

Not Applicable

• Conditions: Psoriasis Vulgaris; Psoriasis; Periodontitis
• Interventions: Other: Non-surgical periodontal treatment

• Registration Number: NCT05311501
• Lead Sponsor: University of Siena

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-25
• Study First Posted: 2022-04-05
• Study Start: 2022-05-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-17
• Last Update Posted: 2022-06-21
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate periodontal treatment	Non-surgical periodontal treatment	Right after the execution of a complete periodontal chart, non-surgical periodontal treatment (NST) was performed, according to the most recent clinical guidelines. NST 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.

Primary Outcome Measures

Name	Time	Method
PASI (Psoriasis Area and Severity Index)- 10 weeks	PASI was registered 10 weeks after 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 (Psoriasis Area and Severity Index)- Baseline	PASI was registered at 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.

Secondary Outcome Measures

Name	Time	Method
Body Surface Area (BSA)- 10 weeks	BSA was registered 10 weeks after 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.
Body Surface Area (BSA)- Baseline	BSA was registered at 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.

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Senese; 🇮🇹 Siena, Italy