NCT07270705

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: ENIKAM d.o.o. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Gingivitis is a reversible inflammation of the gums caused by the accumulation of dental plaque. Without appropriate intervention-such as proper oral hygiene and plaque removal-gingivitis can progress to periodontitis, leading to clinical attachment loss, alveolar bone resorption, and ultimately tooth loss. Gingivitis can be managed with regular and proper tooth brushing and the use of interdental brushes. In cases of more extensive inflammation affecting multiple or all teeth, dental treatment may be required, including scaling, air polishing, or both. Depending on the dentist's assessment, inflamed gums may also be treated with antibiotic therapy. As an adjunctive therapy to manage inflamed gums and maintain proper oral hygiene, the use of mouth rinses or oral solutions containing chlorhexidine, hyaluronic acid, chitosan, or active oxygen (peroxide) is recommended. These agents have antimicrobial properties, help reduce plaque accumulation, and support tissue healing. Mouth rinses containing hydrogen peroxide have been used for over a century as an adjunct to mechanical plaque removal and for the prevention or management of oral infections. Despite long-term use, clinical studies on hydrogen peroxide-based mouth rinses are limited and vary in design, which makes comparison of results difficult. One of the objectives of the proposed post-marketing clinical study is to generate data on the safety and effectiveness of hydrogen peroxide mouth rinses as adjunctive therapy in the treatment of gingivitis. The study will evaluate two concentrations of hydrogen peroxide mouth rinses: a 1.5% solution (Oroxid® sensitive) and a 3% solution (Oroxid® forte).

Conditions

• Gingivitis

Interventions

Type	Name	Description
DEVICE	OROXID® forte oral solution	Patients will use OROXID® forte oral solution two to three times daily for 4 weeks as an adjunct to standard care.
DEVICE	OROXID® sensitive oral solution	Patients will use OROXID® sensitive oral solution two to three times daily for 4 weeks as an adjunct to standard care.
OTHER	Standard of Care	Patients will receive standard of care, consisting of proper tooth brushing without the use of any mouthwash or other products intended to maintain oral hygiene or reduce oral bacterial load.

Timeline

• Start date: 2025-11-22
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2025-12-08
• Last updated: 2025-12-08

Locations

2 sites across 1 country: Slovenia