PsoriasisNCT04722094
Prevalence of Periodontitis in Patients With Plaque Psoriasis. A Cross-sectional Study
An observational study of Psoriasis and Plaque Psoriasis, run by University of Siena at 1 site in Italy.
Trial summary
Psoriasis is a chronic inflammatory disease with a multi-factorial etiology which affects the epidermis and dermis. It affects around 1-3% of the general population and its most frequent form is plaque psoriasis (around 80-90% of the overall psoriasis cases). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis, Plaque Psoriasis, Periodontal Diseases
- What is being tested?
- Full periodontal chart and Saliva sampling
- How many people
- 147 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jan 2021to 25 Aug 2021
- Phase
- Observational
- 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
Study population: All patients affected by Plaque Psoriasis and meeting the inclusion criteria will be screened for the inclusion in the present study.
Who may be able to join
- Age between 18 and 70 years old
- Diagnosis of plaque psoriasis
- Ability and willingness to give informed consent
Who cannot join
- Inability of unwillingness to give informed consent
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOUS
Siena, 53100
Nicola Discepoli, ndiscepoli@me.com
About this study
Psoriasis is a chronic inflammatory disease with a multi-factorial etiology which affects the epidermis and dermis. It affects around 1-3% of the general population and its most frequent form is plaque psoriasis (around 80-90% of the overall psoriasis cases). Psoriasis severity and extension are usually measured through 2 scores: Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA). Periodontitis is a chronic inflammatory disease mediated by the biofilm and with a multi-factorial etiology. Its manifestation entails the destruction of the periodontal tissues surrounding the teeth; the final stage of disease is characterised by tooth loss. Periodontitis severity and extension are usually evaluated through surrogate variables such as: BoP (Bleeding on Probing), PPD (Probing Pocket Depth) e REC (Recession). Both diseases present overlapping genetic and pathophysiologic features, as well as common risk factors (e.g. genetic polymorphisms, smoking habit, obesity, diabetes etc.).
miRNAs are small non-coding molecules involved in the regulation of various biologic processes thanks to their interaction with mRNAs. Active inflammatory processes either in the oral cavity or at a systemic level tend to alter the concentration of salivary miRNAs. No study so far has ever profiled the levels of specific salivary miRNAs in patients with psoriasis and periodontitis.
Some case-control studies highlighted a higher prevalence of periodontitis in patients with psoriasis when compared to healthy controls. Nonetheless, epidemiological data regarding periodontitis prevalence in patients with psoriasis are lacking; moreover, few data are available regarding the relationship between the severity of psoriasis and the severity of periodontitis, together with the effect of common risk factors (e.g. diet, obesity, physical activity, sleep quality etc.).
- Conditions
- Psoriasis, Plaque Psoriasis, Periodontal Diseases, Periodontitis
- Being tested
- Full periodontal chart, Saliva sampling
- Medical subject headings
- Psoriasis, Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full periodontal chartDiagnostic test
A full periodontal chart will be carried out including all biometric periodontal variables: Probing Pocket Depth (PPD), Bleeding on Probing (BoP), presence of Plaque, recession (REC), Full Mouth Plaque Score (FMPS), Full Mouth Bleeding Score (FMBS), presence of furcation and mobility. Periodontal status, as assessed by the periodontal chart, will be evaluated following the New Classification of Periodontal and Peri implant diseases.
Saliva samplingOther
Saliva samples for miRNAs detection will be taken before starting the visit.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Psoriasis | All patients pertaining to the Unit of Dermatology and affected by psoriasis will be screened for the inclusion in the study Receives: Diagnostic Test: Full periodontal chart; Other: Saliva sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Periodontitis in patients with Plaque psoriasis
The prevalence of patients with a diagnosis of periodontitis among the included cohort will be measured.
Measured: Baseline
Secondary outcomes (1)
relationship between salivary miRNAs concentration and the severity of psoriasis and periodontitis
salivary levels of miRNAs will be related to the severity of psoriasis and periodontitis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start25 Jan 2021
- Primary completion25 Jun 2021 (estimated)
- Study completion25 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Discepoli, University of Siena
- Investigators
- Nicola Discepoli, DDS, MsC, PhD, Principal investigator, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722094
- Sponsor's protocol ID
- PSO001
- Status last verified
- Feb 2021
- First submitted
- 19 Jan 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Periodontitis in Patients With Plaque Psoriasis. A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04722094
- Acronym / sponsor ID
- PSO001
- Conditions
- Psoriasis, Plaque Psoriasis, Periodontal Diseases, Periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 25 Jun 2021 (estimated)
- Study completion
- 25 Aug 2021 (estimated)
- First posted
- 25 Jan 2021 (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.
Psoriasis is a chronic inflammatory disease with a multi-factorial etiology which affects the epidermis and dermis. It affects around 1-3% of the general population and its most frequent form is plaque psoriasis (around 80-90% of the overall psoriasis cases). Psoriasis severity and extension are usually measured through 2 scores: Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA). Periodontitis is a chronic inflammatory disease mediated by the biofilm and with a multi-factorial etiology. Its manifestation entails the destruction of the periodontal tissues surrounding the teeth; the final stage of disease is characterised by tooth loss. Periodontitis severity and extension are usually evaluated through surrogate variables such as: BoP (Bleeding on Probing), PPD (Probing Pocket Depth) e REC (Recession). Both diseases present overlapping genetic and pathophysiologic features, as well as common risk factors (e.g. genetic polymorphisms, smoking habit, obesity, diabetes etc.).
miRNAs are small non-coding molecules involved in the regulation of various biologic processes thanks to their interaction with mRNAs. Active inflammatory processes either in the oral cavity or at a systemic level tend to alter the concentration of salivary miRNAs. No study so far has ever profiled the levels of specific salivary miRNAs in patients with psoriasis and periodontitis.
Some case-control studies highlighted a higher prevalence of periodontitis in patients with psoriasis when compared to healthy controls. Nonetheless, epidemiological data regarding periodontitis prevalence in patients with psoriasis are lacking; moreover, few data are available regarding the relationship between the severity of psoriasis and the severity of periodontitis, together with the effect of common risk factors (e.g. diet, obesity, physical activity, sleep quality etc.).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Psoriasis | – | Diagnostic Test: Full periodontal chart, Other: Saliva samplingAll patients pertaining to the Unit of Dermatology and affected by psoriasis will be screened for the inclusion in the study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients affected by Plaque Psoriasis and meeting the inclusion criteria will be screened for the inclusion in the present study.
Key inclusion criteria (3 listed)
- Age between 18 and 70 years old
- Diagnosis of plaque psoriasis
- Ability and willingness to give informed consent
Key exclusion criteria (2 listed)
- Inability of unwillingness to give informed consent
- Pregnancy or lactation
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 |
|---|---|---|
| Full periodontal chartA full periodontal chart will be carried out including all biometric periodontal variables: Probing Pocket Depth (PPD), Bleeding on Probing (BoP), presence of Plaque, recession (REC), Full Mouth Plaque Score (FMPS), Full Mouth Bleeding Score (FMBS), presence of furcation and mobility. Periodontal status, as assessed by the periodontal chart, will be evaluated following the New Classification of Periodontal and Peri implant diseases. | Diagnostic test | Patients with Psoriasis |
| Saliva samplingSaliva samples for miRNAs detection will be taken before starting the visit. | Other | Patients with Psoriasis |
Primary outcome
Prevalence of Periodontitis in patients with Plaque psoriasis
Time frame: Baseline
The prevalence of patients with a diagnosis of periodontitis among the included cohort will be measured.
1 secondary outcome
relationship between salivary miRNAs concentration and the severity of psoriasis and periodontitis
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Nicola Discepoli, DDS, MsC, PhD principal investigator
University of Siena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Plaque 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 3 inclusion and 2 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 24 Feb 2021. 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?
Contact Nicola Discepoli, DDS, MsC, PhD (0577 585772, nicola.discepoli2@unisi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Periodontitis in patients with Plaque psoriasis (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2021.