search
Back to results

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

Primary Purpose

Psoriasis Vulgaris, Psoriasis, Periodontitis

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Non-surgical periodontal treatment
Sponsored by
University of Siena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Azienda Ospedaliero Universitaria Senese

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate periodontal treatment

Delayed Periodontal treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 (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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 16, 2022
Last Updated
June 17, 2022
Sponsor
University of Siena
search

1. Study Identification

Unique Protocol Identification Number
NCT05311501
Brief Title
Impact of Non-surgical Periodontal Therapy in the Management of Plaque Psoriasis.
Official Title
Impact of Non-surgical Periodontal Therapy in the Management of Plaque Psoriasis. A Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Siena

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris, Psoriasis, Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate periodontal treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Periodontal treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Non-surgical periodontal treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
PASI (Psoriasis Area and Severity Index)- Baseline
Description
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.
Time Frame
PASI was registered at baseline.
Title
PASI (Psoriasis Area and Severity Index)- 10 weeks
Description
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.
Time Frame
PASI was registered 10 weeks after baseline.
Secondary Outcome Measure Information:
Title
Body Surface Area (BSA)- Baseline
Description
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.
Time Frame
BSA was registered at baseline.
Title
Body Surface Area (BSA)- 10 weeks
Description
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.
Time Frame
BSA was registered 10 weeks after baseline.
Other Pre-specified Outcome Measures:
Title
Salivary Concentration of miRNAs- Baseline
Description
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.
Time Frame
Salivary Concentration of miRNAs was registered at baseline.
Title
Salivary Concentration of miRNAs- 10 weeks
Description
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.
Time Frame
Salivary Concentration of miRNAs was registered 10 weeks after baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Azienda Ospedaliero Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD will be made available upon reasonable request.

Learn more about this trial

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

We'll reach out to this number within 24 hrs