The Effect of Periodontal Treatment on Psoriasis
Primary Purpose
Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Psoriatic measurements
Non-surgical periodontal treatment
saliva samples
Sponsored by
About this trial
This is an interventional prevention trial for Periodontal Diseases focused on measuring Psoriasis
Eligibility Criteria
Inclusion Criteria:
- the presence at least 20 remaining teeth,
- the presence of Stage I or Stage II Periodontitis,
- the presence of diagnosed psoriasis.
Exclusion Criteria:
- 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.
Sites / Locations
- Gaziosmanpasa University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Test Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03939936
Brief Title
The Effect of Periodontal Treatment on Psoriasis
Official Title
Effects of Non-surgical Periodontal Therapy on Inflammatory Markers of Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
January 30, 2018 (Actual)
Study Completion Date
February 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ozge Gokturk
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
Psoriasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Psoriatic measurements
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Non-surgical periodontal treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
saliva samples
Intervention Description
Saliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks.
Primary Outcome Measure Information:
Title
Proinflammatory cytokines
Description
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.
Time Frame
Baseline and after 8 weeks
Secondary Outcome Measure Information:
Title
Gingival index
Description
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.
Time Frame
Baseline and after 8 weeks
Title
PASI index
Description
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.
Time Frame
Baseline and after 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the presence at least 20 remaining teeth,
the presence of Stage I or Stage II Periodontitis,
the presence of diagnosed psoriasis.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atiye Ogrum
Organizational Affiliation
Gaziosmanpasa Universty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziosmanpasa University
City
Tokat
ZIP/Postal Code
60250
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Periodontal Treatment on Psoriasis
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