Clinical trial NCT05215431: Periodontal Health Status in Patients with Systemic Sclerosis
Official title: The EFFECTS of NON-SURGICAL PERIODONTAL TREATMENT in PATIENTS with SYSTEMIC SCLEROSIS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Systemic Sclerosis
Periodontitis
Keywords: systemic sclerosis
periodontitis
antioxidants
saliva
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical attachment level (CAL)
timeFrame: one day
measure: Probing depth (PD)
timeFrame: one day
measure: Gingival margin level (GML)
timeFrame: one day
measure: The degree of gingival inflammation
timeFrame: one day
measure: plaque index (PI)
timeFrame: one day
measure: The concentration of vascular endothelial growth factor (VEGF)
timeFrame: baseline and two months after periodontal treatment
measure: The concentration of transforming growth factor beta (TGF-β)
timeFrame: baseline and two months after periodontal treatment
measure: The concentration of interleukin (IL)-17
timeFrame: baseline and two months after periodontal treatment
measure: The concentration of glutathion peroxidase (GPX)
timeFrame: one day
measure: The concentration of uric acid (UA)
timeFrame: one day
measure: The concentration of superoxide dismutase (SOD)
timeFrame: one day
measure: The concentration of tumor necrosis factor alpha
timeFrame: baseline and two months after periodontal treatment
measure: The concentration of C reactive protein
timeFrame: baseline and two months after periodontal treatment
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: baseline and two months after periodontal treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade
Study officials:
affiliation: School of Dental Medicine, University of Belgrade, Serbia
name: Natasa Nikolic Jakoba, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: