Periodontal DiseasesNCT03939936
The Effect of Periodontal Treatment on Psoriasis
A study testing Psoriatic measurements, Non-surgical periodontal treatment and saliva samples in people with Periodontal Diseases, run by Ozge Gokturk at 1 site in Turkey (Türkiye).
Trial summary
There is a relationship between psoriasis and periodontal disease. This relationship may be double-sided. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Psoriatic measurements, Non-surgical periodontal treatment and saliva samples
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2017to 15 Feb 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- the presence at least 20 remaining teeth,
- the presence of Stage I or Stage II Periodontitis,
- the presence of diagnosed psoriasis.
Who cannot join
- patients who had the immune-inflammatory disease and require antibiotic prophylaxis,
- patients who received periodontal treatment prior to 6 months,
- women who were breastfeeding or pregnant,
- patients using medicines such as antibiotics, anti-inflammatory drugs, immune-suppressants.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University
Tokat Province, 60250
About this study
Official title: Effects of Non-surgical Periodontal Therapy on Inflammatory Markers of Psoriasis
There is a relationship between psoriasis and periodontal disease. This relationship may be double-sided.
Read the detailed description
The aim of this randomized controlled clinical study was to determine the effect of non-surgical mechanical periodontal treatment on psoriasis. The study population consisted of 92 periodontitis patients with psoriasis who had untreated periodontal disease. Two randomized groups were formed from these patients. Immediate periodontal treatment (test group, n = 46) and delayed periodontal treatment (control group, n = 46). Clinical periodontal measures, saliva interleukin 2, interleukin 6 and secretory immunoglobulin A levels and PASI scores were performed at baseline and 8th week in control and test group.
- Conditions
- Periodontal Diseases
- Being tested
- Psoriatic measurements, Non-surgical periodontal treatment, saliva samples
- Keywords
- Psoriasis
- Medical subject headings
- Periodontal Diseases, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psoriatic measurementsOther
Psoriasis Area and Severity Index (PASI) was performed baseline and after 8 weeks. Saliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks.
Non-surgical periodontal treatmentOther
Non-surgical periodontal treatment was performed baseline and after 8 weeks. Saliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks.
saliva samplesOther
Saliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Active comparator | Psoriatic measurements and saliva samples were taken from periodontal disease patients before treatment and after 8 weeks.
Intervention: Non-surgical periodontal treatment was performed and the Psoriasis Area and Severity Index (PASI) was filled, saliva samples were taken. Receives: Other: Psoriatic measurements; Other: Non-surgical periodontal treatment; Other: saliva samples |
| Control Group | Placebo comparator | Psoriatic measurements and saliva samples were taken from periodontal disease patients at the baseline and after 8 weeks without the periodontal treatment.
Intervention: Psoriasis Area and Severity Index (PASI) was filled, saliva samples were taken. Receives: Other: Psoriatic measurements; Other: saliva samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proinflammatory cytokines
The changes in proinflammatory cytokines levels within 8 weeks. Higher values represent a worse outcome. The decrease in proinflammatory cytokines levels is expected after periodontal treatment.
Measured: Baseline and after 8 weeks
Secondary outcomes (2)
Gingival index
The changes in gingival index level after periodontal treatment. Gingival index was measured for determining the severity of disease and clinical outcome. Higher values represent a worse outcome. After periodontal treatment, a reduction in gingival index value is expected.
Measured: Baseline and after 8 weeks
PASI index
The changes in PASI index level after periodontal treatment. PASI index was measured for determining the severity of psoriasis disease. Higher values represent a worse outcome. After periodontal treatment, a reduction in PASI index value is expected.
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 May 2017
- Primary completion30 Jan 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ozge Gokturk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ozge Gokturk, Tokat Gaziosmanpasa University
- Investigators
- Atiye Ogrum, Principal investigator, Gaziosmanpasa Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939936
- Sponsor's protocol ID
- 17-KAEK-44
- Status last verified
- May 2019
- First submitted
- 26 Apr 2019
- Last updated
- 9 May 2019
- 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 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-surgical Periodontal Therapy on Inflammatory Markers of Psoriasis
- ClinicalTrials.gov ID
- NCT03939936
- Acronym / sponsor ID
- 17-KAEK-44
- Conditions
- Periodontal Diseases
- Keywords
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ozge GokturkUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 7 May 2019 (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.
There is a relationship between psoriasis and periodontal disease. This relationship may be double-sided.
Detailed description
The aim of this randomized controlled clinical study was to determine the effect of non-surgical mechanical periodontal treatment on psoriasis. The study population consisted of 92 periodontitis patients with psoriasis who had untreated periodontal disease. Two randomized groups were formed from these patients. Immediate periodontal treatment (test group, n = 46) and delayed periodontal treatment (control group, n = 46). Clinical periodontal measures, saliva interleukin 2, interleukin 6 and secretory immunoglobulin A levels and PASI scores were performed at baseline and 8th week in control and test group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Active comparator | Other: Psoriatic measurements, Other: Non-surgical periodontal treatment, Other: saliva samplesPsoriatic measurements and saliva samples were taken from periodontal disease patients before treatment and after 8 weeks. Intervention: Non-surgical periodontal treatment was performed and the Psoriasis Area and Severity Index (PASI) was filled, saliva samples were taken. |
| Control Group | Placebo comparator | Other: Psoriatic measurements, Other: saliva samplesPsoriatic measurements and saliva samples were taken from periodontal disease patients at the baseline and after 8 weeks without the periodontal treatment. Intervention: Psoriasis Area and Severity Index (PASI) was filled, saliva samples were taken. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- the presence at least 20 remaining teeth,
- the presence of Stage I or Stage II Periodontitis,
- the presence of diagnosed psoriasis.
Key exclusion criteria (4 listed)
- patients who had the immune-inflammatory disease and require antibiotic prophylaxis,
- patients who received periodontal treatment prior to 6 months,
- women who were breastfeeding or pregnant,
- patients using medicines such as antibiotics, anti-inflammatory drugs, immune-suppressants.
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 |
|---|---|---|
| Psoriatic measurementsPsoriasis Area and Severity Index (PASI) was performed baseline and after 8 weeks. Saliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks. | Other | Control Group, Test Group |
| Non-surgical periodontal treatmentNon-surgical periodontal treatment was performed baseline and after 8 weeks. Saliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks. | Other | Test Group |
| saliva samplesSaliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks. | Other | Control Group, Test Group |
Primary outcome
Proinflammatory cytokines
Time frame: Baseline and after 8 weeks
The changes in proinflammatory cytokines levels within 8 weeks. Higher values represent a worse outcome. The decrease in proinflammatory cytokines levels is expected after periodontal treatment.
2 secondary outcomes
Gingival index
Time frame: Baseline and after 8 weeks
PASI index
Time frame: Baseline and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- 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.
Atiye Ogrum principal investigator
Gaziosmanpasa Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psoriatic measurements, Non-surgical periodontal treatment and saliva samples in people with Periodontal Diseases, run by Ozge Gokturk at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 9 May 2019. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proinflammatory cytokines (time frame: Baseline and after 8 weeks). 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 9 May 2019.