Antioxidant Profile in Patients With Systemic Sclerosis and Periodontitis

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05215431
• Other study ID #: Unique Protocol ID: UBelgrade7
• Status: Active, not recruiting
• Start date: February 5, 2019
• Est. completion date: March 1, 2024

Study information

• Verified date: November 2023
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: March 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Serbia	Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

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