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

Study Overview
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Brief Summary
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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.

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

Conditions
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Psoriasis Vulgaris, Psoriasis, Periodontitis

Intervention / Treatment
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* Other: Non-surgical periodontal treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate periodontal treatment<br>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. | Other: Non-surgical periodontal treatment<br>* 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.<br>|
| No Intervention: Delayed Periodontal treatment<br>Right after the execution of a complete periodontal chart, the patient is informed regarding their group allocation, according to which they are asked to delay NST for 10 weeks. 10 weeks after baseline examination, 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. |