Researchers are now recruiting participants for a groundbreaking clinical trial investigating the efficacy and safety of OROXID® oral solutions in managing periodontal disease. Sponsored by ENIKAM d.o.o., this trial aims to compare the effectiveness of OROXID® forte and sensitive solutions against the current standard of care.
This study’s outcomes may impact treatment options for periodontitis patients. Regulatory, clinical, and quality professionals should watch for updates as the trial progresses.
In this article:
- What is being tested?
- Trial design and objectives
- Who should pay attention?
- FAQ
- Conclusion
- Disclaimer
- Announcement source
What is being tested?
OROXID® oral solutions, available in forte and sensitive variants, are medical devices designed to support oral hygiene and reduce inflammation. The clinical trial will evaluate their performance and safety for patients diagnosed with periodontal disease, focusing on their capacity to manage symptoms and improve oral health outcomes compared to standard care methods.
Standard care for periodontitis typically involves professional dental cleanings, antibacterial treatments, and ongoing maintenance. By introducing OROXID® oral solutions as part of patient care, researchers hope to demonstrate measurable benefits beyond traditional protocols.
Trial design and objectives
Recruitment details
The trial is currently recruiting participants, as listed on ClinicalTrials.gov. Eligible candidates are adults diagnosed with periodontal disease who meet predefined inclusion and exclusion criteria.
Assessment strategy
This investigation will employ a comparative study design, holding OROXID® forte and sensitive solutions up against standard care. Researchers aim to collect data on various metrics including reduction in inflammation, bacterial load, patient-reported outcomes, and device tolerability.
Regulatory insights
Given the medical device classification of OROXID® oral solutions, compliance with regulatory expectations for safety and performance will be paramount. Clinical teams will examine whether these devices meet stated claims under MDR Annex XIV standards.
Who should pay attention?
The trial is relevant for clinical research professionals, dental practitioners, regulatory teams, and device manufacturers specializing in oral care. Insights from the study may inform clinical practices, future product designs, and regulatory pathways for similar devices.
Stakeholders in the medical device sector should monitor recruitment progress and subsequent results, as they may indicate new trends in non-invasive periodontitis treatments.
FAQ
1. What is periodontal disease?
Periodontal disease refers to advanced gum infections causing inflammation and potential damage to soft tissues and bone supporting teeth. Left untreated, it can lead to tooth loss.
2. How does OROXID® work?
OROXID® solutions are engineered to reduce bacterial levels and inflammation while supporting general oral hygiene. Their active ingredients aim to improve oral health outcomes during regular use.
3. What is the significance of clinical trials like this?
Clinical trials provide evidence-based data on the efficacy and safety of medical devices. Results help validate product claims and support regulatory approvals.
Conclusion
As recruitment continues, ENIKAM d.o.o.’s evaluation of OROXID® oral solutions promises data that may influence periodontitis treatment protocols. Professionals across clinical research, regulatory affairs, and dentistry should track its results for future implications in oral health management.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or medical advice. Please consult appropriate professionals for guidance specific to your field.
Announcement source
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07257887?term=medical+device