The Effect of Periodontal Treatment on Psoriasis

• ClinicalTrials.gov Identifier: NCT03939936
• Recruitment Status: Completed
• First Posted: May 7, 2019
• Last Update Posted: May 9, 2019
• Sponsor: Ozge Gokturk
• Information provided by (Responsible Party): Ozge Gokturk, Tokat Gaziosmanpasa University

Study Description

Brief Summary:

There is a relationship between psoriasis and periodontal disease. This relationship may be double-sided.

Condition or disease	Intervention/treatment	Phase
Periodontal Diseases	Other: Psoriatic measurements; Other: Non-surgical periodontal treatment; Other: saliva samples	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of Non-surgical Periodontal Therapy on Inflammatory Markers of Psoriasis
• Actual Study Start Date: May 1, 2017
• Actual Primary Completion Date: January 30, 2018
• Actual Study Completion Date: February 15, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Turkey

Gaziosmanpasa University

Tokat, Turkey, 60250

Sponsors and Collaborators

Ozge Gokturk

Investigators

• Principal Investigator: Atiye Ogrum; Gaziosmanpasa Universty

More Information

• Responsible Party: Ozge Gokturk, Principal Investigator, Tokat Gaziosmanpasa University
• ClinicalTrials.gov Identifier: NCT03939936
• Other Study ID Numbers: 17-KAEK-44
• First Posted: May 7, 2019
• Last Update Posted: May 9, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ozge Gokturk, Tokat Gaziosmanpasa University:

Psoriasis

Additional relevant MeSH terms:

Periodontal Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Mouth Diseases; Stomatognathic Diseases