Periodontal Health Status in Patients with Systemic Sclerosis

University of Belgrade

Status: Enrolling

Conditions: Periodontitis; Systemic Sclerosis

Treatments: Diagnostic Test: Activity of antioxidants in unstimulated saliva (GPX, SOD, UA); Procedure: periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis; Diagnostic Test: Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid; Procedure: Periodontal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05215431

Unique Protocol ID: UBelgrade7

Details and patient eligibility

About

The aim of the research will be to evaluate the effects of NSPT on clinical periodontal parameters, level of antioxidants in unstimulated saliva and the levels of biomarkers (VEGF, TGF-β, IL-17) in the GCF in SSc patients in comparison with systemically healthy controls. 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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

systemic sclerosis group

Experimental group

Description:

Patients with established diagnoses of systemic sclerosis and periodontitis

Treatment:

Procedure: Periodontal treatment

Diagnostic Test: Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid

Procedure: periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis

Diagnostic Test: Activity of antioxidants in unstimulated saliva (GPX, SOD, UA)

periodontitis group

Experimental group

Description:

Systemically healthy periodontitis patients

Treatment:

Procedure: Periodontal treatment

Diagnostic Test: Total cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid

Procedure: periodontal examination's, determination of salivary antioxidants and cytokine levels (VEGF, TGF-β, Il-17) in gingival crevicular fluid, Non-surgical therapy of periodontitis

Diagnostic Test: Activity of antioxidants in unstimulated saliva (GPX, SOD, UA)