Antioxidant Profile in Patients With Systemic Sclerosis and Periodontitis

November 28, 2023 updated by: Natasa Nikolic Jakoba, University of Belgrade

Antioxidant Profile in Unstimulated Saliva in Patients With Systemic Sclerosis and Periodontitis

The aim of the research will be to compare periodontal status and level of antioxidants in unstimulated saliva of systemic sclerosis patients with periodontitis and systemically healthy periodontitis patients.

Twenty systemic sclerosis patients with periodontitis (SS group) and twenty systemically healthy periodontitis patients (P group) will be enrolled in the present study. The results may indicate higher periodontal destruction and antioxidant perturbations in unstimulated saliva of systemic sclerosis patients with periodontitis compared to systemically healthy periodontitis patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

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

Study Contact

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with established diagnoses of systemic sclerosis according to the American Rheumatism Association criteria for scleroderma were referred from the Institut for rheumatology, Belgrade, Serbia to the Department of Periodontology, School of Dental Medicine, University of Belgrade, Serbia for screening.

After the exclusion of patients who did not meet the inclusion criteria or declined to participate, 2O systemic sclerosis patients with periodontitis were enrolled in the present study.

Twenty systemically healthy patients with periodontitis who were seeking care at the Department of Periodontology, School of Dental Medicine, University of Belgrade, Serbia were recruited in the control group.

Description

Inclusion Criteria:

  • established diagnoses of systemic sclerosis and periodontitis (study group),
  • age ≥ 18
  • presence of minimum 12 teeth

Exclusion Criteria:

  • concurrent inflammatory mediated rheumatic diseases
  • pregnancy or lactation
  • active cigarette smokers
  • a history of periodontal, antibiotics or non-steroidal drug therapy in the past 6 months.

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
systemic sclerosis group
Patients with established diagnoses of systemic sclerosis and periodontitis
Diagnostic test: periodontal examination's and determination of salivary antioxidants
Periodontal parameters such probing depth (PD), clinical attachment level (CAL) and gingival margin level has been recorded on six sites of each tooth using a manual periodontal probe. The degree of gingival inflammation has been assessed using the Loe and Silness (LSGI) gingival index. Activity of antioxidants in unstimulated saliva (GPX, SOD, UA) has been determined using the colorimetric method and commercial kits.
periodontitis group
Systemically healthy periodontitis patients
Diagnostic test: periodontal examination's and determination of salivary antioxidants
Periodontal parameters such probing depth (PD), clinical attachment level (CAL) and gingival margin level has been recorded on six sites of each tooth using a manual periodontal probe. The degree of gingival inflammation has been assessed using the Loe and Silness (LSGI) gingival index. Activity of antioxidants in unstimulated saliva (GPX, SOD, UA) has been determined using the colorimetric method and commercial kits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment level (CAL)
Time Frame: one day
Measuring the CAL by periodontal probe, measured in mm
one day
Probing depth (PD)
Time Frame: one day
Measuring the PD by periodontal probe, measured in mm
one day
Gingival margin level (GML)
Time Frame: one day
Measuring the GML by periodontal probe, measured in mm
one day
The degree of gingival inflammation
Time Frame: one day
The degree of gingival inflammation was assessed using the Loe and Silness (LSGI) gingival index.
one day
plaque index (PI)
Time Frame: one day
Evaluation of oral hygiene status was recorded with a Silness Loe plaque index (PI).
one day
glutathion peroxidase (GPX)
Time Frame: one day
Activity level of GPX, determined using the colorimetric method and commercial kits.
one day
superoxide dismutase (SOD)
Time Frame: one day
Activity level of SOD, determined using the colorimetric method and commercial kits.
one day
uric acid (UA)
Time Frame: one day
Activity level of UA, determined using the colorimetric method and commercial kits.
one day

Collaborators and Investigators

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

Sponsor

University of Belgrade

Investigators

  • Principal Investigator: Natasa Nikolic Jakoba, DDS, PhD, School of dental medicine, University of Belgrade, Serbia

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)

February 5, 2019

Primary Completion (Actual)

November 1, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

January 18, 2022

First Submitted That Met QC Criteria

January 18, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Unique Protocol ID: UBelgrade7

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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