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

NCT05311501 | Unknown

• 1 other identifier: TPSO001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Vulgaris; Psoriasis; Periodontitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Body Surface Area (BSA)- Baseline

  BSA was registered at baseline.

• Body Surface Area (BSA)- 10 weeks

  BSA was registered 10 weeks after baseline.

Other Outcomes (2)

• Salivary Concentration of miRNAs- Baseline

  Salivary Concentration of miRNAs was registered at baseline.

• Salivary Concentration of miRNAs- 10 weeks

  Salivary Concentration of miRNAs was registered 10 weeks after baseline.

Study Arms (2)

Immediate periodontal treatment

EXPERIMENTAL

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

Delayed Periodontal treatment

NO INTERVENTION

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.

Interventions

Non-surgical periodontal treatment OTHER

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.

Immediate periodontal treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Senese

Siena, 53100, Italy

Location

Related Publications (1)

• Marruganti C, Romandini M, Gaeta C, Trovato E, Cinotti E, Rubegni P, D'Aiuto F, Grandini S. Treatment of periodontitis ameliorates the severity and extent of psoriasis-A randomized clinical trial. J Periodontal Res. 2025 Feb;60(2):134-143. doi: 10.1111/jre.13314. Epub 2024 Jun 20.

  PMID: 38899599 DERIVED

MeSH Terms

Conditions

Psoriasis; Periodontitis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 5, 2022
• Study Start: May 10, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

IT (1)