NCT03939936

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

9 months

First QC Date

April 26, 2019

Last Update Submit

May 7, 2019

Conditions

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and after 8 weeks

Secondary Outcomes (2)

  • Gingival index

    Baseline and after 8 weeks

  • PASI index

    Baseline and after 8 weeks

Study Arms (2)

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.

Other: Psoriatic measurementsOther: Non-surgical periodontal treatmentOther: 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.

Other: Psoriatic measurementsOther: saliva samples

Interventions

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.

Control GroupTest Group

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.

Test Group

Saliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks.

Control GroupTest Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • the presence at least 20 remaining teeth,
  • the presence of Stage I or Stage II Periodontitis,
  • the presence of diagnosed psoriasis.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University

Tokat Province, 60250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal DiseasesPsoriasis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Atiye Ogrum

    Gaziosmanpasa Universty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 26, 2019

First Posted

May 7, 2019

Study Start

May 1, 2017

Primary Completion

January 30, 2018

Study Completion

February 15, 2018

Last Updated

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations