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ID07257887

Study of OROXID Oral Solutions for Treating Periodontitis Evaluating Safety and Effectiveness in Adults with Stage III Periodontitis

Led by ENIKAM d.o.o. · Updated on 2025-12-02

90

Participants Needed

2

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Periodontitis is a chronic inflammatory disease that damages the structures supporting the teeth, often caused by bacteria in dental plaque. It usually starts as gingivitis, which is a reversible gum inflammation. Without proper oral hygiene and treatment, gingivitis can progress to periodontitis, leading to loss of tooth support and eventually tooth loss. Early diagnosis and treatment are important to prevent this progression. This study aims to evaluate the safety and effectiveness of two hydrogen peroxide mouth rinses as additional treatments for periodontitis. The study will compare two concentrations of hydrogen peroxide mouth rinses a 1.5% solution called Oroxidae sensitive and a 3% solution called Oroxidae forte. Participants will use either oral solution two to three times daily for 12 weeks alongside their standard dental care. A control group will receive standard care alone, which includes proper tooth brushing without mouth rinses or other products aimed at reducing oral bacteria. The study is randomized and does not involve blinding. Participants will be assessed at the start and after 12 weeks for gum health using measures such as probing depth and bleeding on probing. Additional evaluations include plaque and gingival indices, infection rates, and monitoring of adverse events throughout the 12-week period. The study involves adults with Stage III, Grade B periodontitis who meet specific dental and health criteria. The goal is to gather more data on how these mouth rinses may support periodontal treatment over three months of use.

CONDITIONS

Brief Title

Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Periodontitis

Research Team

D

Dominika Tompa Majcen, MPharm

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