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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05311501
Enrollment
74
Registered
2022-04-05
Start date
2022-05-10
Completion date
2023-01-01
Last updated
2022-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis, Psoriasis, Psoriasis Vulgaris

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.

Interventions

OTHERNon-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.

Sponsors

University of Siena
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
PASI (Psoriasis Area and Severity Index)- BaselinePASI 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.
PASI (Psoriasis Area and Severity Index)- 10 weeksPASI 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.

Secondary

MeasureTime frameDescription
Body Surface Area (BSA)- BaselineBSA 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.
Body Surface Area (BSA)- 10 weeksBSA 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.

Other

MeasureTime frameDescription
Salivary Concentration of miRNAs- BaselineSalivary Concentration of miRNAs was registered at 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- 10 weeksSalivary Concentration of miRNAs was registered 10 weeks after 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026