Antioxidant Profile in Patients With Systemic Sclerosis and Periodontitis

Sponsor

University of Belgrade (Other)

Overall Status

Recruiting

CT.gov ID

NCT05215431

Collaborator

(none)

Enrollment

Location

41.4

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Sclerosis Periodontitis	Diagnostic Test: periodontal examination's and determination of salivary antioxidants

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Feb 5, 2019

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jul 20, 2022

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.