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Warning: The information provided on this page is for general knowledge purposes only and does not replace the official Instructions for Use (IFU), which are supplied with the medical device. This page does not constitute an electronic IFU either.

OROSOL : Treatment for oral mucositis

OROSOL is an innovative medical device oral spray designed to treat oral mucositis induced by radiotherapy or chemotherapy. With its protective barrier effect, osmotic and cleaning effect, as well as cellular repair and growth effect, OROSOL provides a significant reduction in pain, burns, infections, and mucositis severity in as little as 20-30 minutes. Clinical results show continued improvement with regular use, offering patients long-lasting relief and improved quality of life.

This unique formulation is composed of over 99% natural-origin ingredients, ensuring a high-quality product that combines efficacy with excellent safety.

Clinical trial

An open, multicentric, pilot study

Population

This product is intended for adults and children aged eight years and older

Indication

Used in adults and children aged eight years and older for the treatment of oral mucositis induced by chemotherapy or radiotherapy.

Patient's benefits

Reduces mucositis severity
Immediate and sustained pain relief
Burning sensation alleviation
Improved oral hydration
Helps reduce the formation and size of ulcers
Improved quality of life
Helps enhance nutrition

Mode of Action

Mechanical Cleaning: The product works to cleanse the oral cavity, removing impurities and contaminants that can exacerbate inflammation and delay healing.
Protective Barrier: OROSOL creates a protective barrier in the oral cavity, shielding the mucous membranes from further damage and allowing the healing process to begin.
Cellular Repair: OROSOL promotes the repair and growth of cells in the oral cavity, accelerating the healing process and reducing the duration of symptoms.

Clinical Trial

OROSOL® has shown strong clinical effectiveness in the management of oral mucositis. In a 28-day clinical trial, patients using OROSOL® experienced a 70% reduction in mucositis severity, compared to just 10% in the control group. There was also a significant decrease in pain (from 7.19 to 2.05) and burning sensation (from 7.25 to 1.92). OROSOL® also reduced infection risk, minimized new ulcer formation, and improved eating ability and oral hydration. The treatment was well tolerated, with only mild and temporary sensations after application. These results support OROSOL® as an effective and safe therapeutic option for improving quality of life in patients with oral mucositis.

Product Details

Indication: Used in adults and children aged eight years and older, for the treatment of oral mucositis induced by chemotherapy or radiotherapy.
Composition: Made from natural-origin ingredients
Presentation: Oral spray 20ml.
Class: MDR Class IIa.
Age: Suitable for adults and children aged eight years and older (8+).
Storage conditions: Below 25°C.
Legal manufacturer: VITROBIO (France).
Product code: OS.