Psoriasis VulgarisNCT05311501
Impact of Non-surgical Periodontal Therapy in the Management of Plaque Psoriasis.
A study testing Non-surgical periodontal treatment in people with Psoriasis Vulgaris and Psoriasis, run by University of Siena at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis Vulgaris, Psoriasis, Periodontitis
- What is being tested?
- Non-surgical periodontal treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Non-surgical Periodontal Therapy in the Management of Plaque Psoriasis. A Randomised Controlled Trial.
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
- Being tested
- Non-surgical periodontal treatment
- Medical subject headings
- Psoriasis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: PASI was registered 10 weeks after baseline.
Secondary outcomes (2)
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.
Measured: 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.
Measured: BSA was registered 10 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start10 May 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Grandini, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311501
- Sponsor's protocol ID
- TPSO001
- Status last verified
- Jun 2022
- First submitted
- 16 Mar 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be made available upon reasonable request.
Publications
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.
PubMed 38899599
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-surgical Periodontal Therapy in the Management of Plaque Psoriasis. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05311501
- Acronym / sponsor ID
- TPSO001
- Conditions
- Psoriasis Vulgaris, Psoriasis, Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate periodontal treatment | Experimental | Other: Non-surgical periodontal treatmentRight 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-surgical periodontal treatmentNon-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. | Other | Immediate periodontal treatment |
Primary outcome
PASI (Psoriasis Area and Severity Index)- Baseline
Time frame: PASI 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 weeks
Time frame: PASI 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.
2 secondary outcomes
Body Surface Area (BSA)- Baseline
Time frame: BSA was registered at baseline.
Body Surface Area (BSA)- 10 weeks
Time frame: BSA was registered 10 weeks after baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Derived from this study: PubMed 38899599Marruganti 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.
- Individual participant dataSharing planned: Undecided. IPD will be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal treatment in people with Psoriasis Vulgaris and Psoriasis, run by University of Siena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PASI (Psoriasis Area and Severity Index)- Baseline (time frame: PASI was registered at baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05311501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.