Evaluating periodontal health in patients with systemic sclerosis
The EFFECTS of NON-SURGICAL PERIODONTAL TREATMENT in PATIENTS with SYSTEMIC SCLEROSIS
This study is testing how a non-surgical gum treatment affects gum health and saliva antioxidant levels in people with systemic sclerosis and gum disease compared to healthy individuals with the same condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | University of Belgrade Academic / other |
| Locations | 1 site (Belgrade) |
| Trial ID | NCT05215431 on ClinicalTrials.gov |
What this trial studies
This research aims to assess the impact of non-surgical periodontal therapy on clinical periodontal parameters and antioxidant levels in saliva among patients with systemic sclerosis and periodontitis. The study will compare twenty patients with systemic sclerosis to twenty systemically healthy individuals with periodontitis. Key biomarkers such as VEGF, TGF-β, and IL-17 will be measured in gingival crevicular fluid to understand the differences in periodontal destruction and antioxidant levels. The findings may provide insights into the unique periodontal challenges faced by patients with systemic sclerosis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with established diagnoses of both systemic sclerosis and periodontitis.
Not a fit: Patients with concurrent inflammatory rheumatic diseases, pregnancy, active smoking habits, or recent periodontal treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved periodontal treatment strategies for patients with systemic sclerosis.
How similar studies have performed: While there is limited data on similar studies specifically addressing systemic sclerosis and periodontal health, the approach of evaluating periodontal therapy in systemic conditions has shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Belgrade
- Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade — Belgrade, Serbia (Recruiting)
Study contacts
- Principal investigator: Natasa Nikolic Jakoba, DDS, PhD — School of Dental Medicine, University of Belgrade, Serbia
- Study coordinator: Natasa Nikolic Jakoba, DDS, PhD
- Email: natasa.nikolic.jakoba@stomf.bg.ac.rs
- Phone: +381112685288
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.