Actively Recruiting
Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Periodontitis
Led by ENIKAM d.o.o. · Updated on 2025-12-02
90
Participants Needed
2
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Periodontitis is a chronic, irreversible inflammatory disease affecting the supporting structures of the teeth. It is most commonly caused by bacteria in dental plaque, also known as biofilm. The disease typically begins as gingivitis, a reversible inflammation of the gums resulting from plaque accumulation. Without appropriate intervention-such as maintaining proper oral hygiene and removing plaque-gingivitis can progress to periodontitis, leading to the loss of clinical attachment, alveolar bone resorption, and eventually tooth loss. Early diagnosis and regular treatment of periodontal disease are essential to prevent disease progression. The treatment of periodontitis is primarily causal and involves the mechanical removal of plaque. Initial therapy is non-surgical, consisting of scaling and root planing, and may be followed by surgical procedures if required. In addition to mechanical cleaning, increasing attention has been given to adjunctive, non-invasive therapies such as mouth rinses or oral solutions containing chlorhexidine or hydrogen peroxide. These agents have antimicrobial properties, help reduce plaque accumulation, and support tissue healing. Hydrogen peroxide mouth rinses have been used for more than a century as an adjunct to mechanical plaque removal and for the prevention or management of oral infections. However, despite their long history of use, clinical studies evaluating hydrogen peroxide-based mouth rinses remain limited and heterogeneous in design, which makes it difficult to compare findings across studies. The objective of this post-marketing clinical study is to generate additional data on the safety and efficacy of a hydrogen peroxide mouth rinse as an adjunctive therapy in the treatment of periodontitis. The study will evaluate two hydrogen peroxide concentrations: a 1.5% solution (Oroxid® sensitive) and a 3% solution (Oroxid® forte).
CONDITIONS
Official Title
Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Periodontitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Systemically healthy participants aged 18 years or older
- Diagnosis of generalized periodontitis, Stage III, Grade B
- Presence of three or more periodontal pockets deeper than 5 mm
- Having at least 16 natural teeth excluding wisdom teeth
- Ability to follow oral hygiene instructions after treatment
- Signed informed consent after full study explanation
You will not qualify if you...
- Periodontal treatment within the past six months
- Dental procedures such as surgery, professional cleaning, scaling and root planing, laser therapy, or piezotome within the past six months
- Periodontitis Stage IV diagnosis
- Use of mouth rinses or oral gels within the past month
- Antibiotic therapy within the past three months
- Ongoing treatment with antihypertensives, antilipemics, antiarrhythmics, or other cardiovascular medications
- Presence of systemic diseases including diabetes, HIV/AIDS, liver diseases, chronic kidney disease, tuberculosis, or autoimmune disorders
- History of cardiovascular diseases like heart attack, angina, heart failure, atrial fibrillation, heart block, peripheral artery disease, or stroke
- Use of immunosuppressive therapy
- Allergy to any ingredients of the study products
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Klinika Križaj Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
2
Ustna medicina d.o.o.
Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
D
Dominika Tompa Majcen, MPharm
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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