The Effect of Periodontal Treatment on Psoriasis

May 7, 2019 updated by: Ozge Gokturk

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tokat, Turkey, 60250
        • Gaziosmanpasa University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Test Group

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.
Other: Psoriatic measurements
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.
Other: Non-surgical periodontal treatment
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.
Other: saliva samples
Saliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks.
Placebo Comparator: Control Group

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.
Other: Psoriatic measurements
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.
Other: saliva samples
Saliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival index
Time Frame: Baseline and after 8 weeks
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.
Baseline and after 8 weeks
PASI index
Time Frame: Baseline and after 8 weeks
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.
Baseline and after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ozge Gokturk

Investigators

  • Principal Investigator: Atiye Ogrum, Gaziosmanpasa Universty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

January 30, 2018

Study Completion (Actual)

February 15, 2018

Study Registration Dates

First Submitted

April 26, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (Actual)

May 7, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2019

Last Update Submitted That Met QC Criteria

May 7, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-KAEK-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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