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

NCT ID: NCT05311501

Last Updated: 2022-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-10

Study Completion Date

2023-01-01

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.

Detailed Description

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Conditions

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Psoriasis Vulgaris Psoriasis Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Immediate 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.

Group Type EXPERIMENTAL

Non-surgical periodontal treatment

Intervention Type 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.

Delayed Periodontal treatment

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Siena

OTHER

Sponsor Role lead

Responsible Party

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Simone Grandini

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliero Universitaria Senese

Siena, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 38899599 (View on PubMed)

Other Identifiers

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TPSO001

Identifier Type: -

Identifier Source: org_study_id

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