OROSOL : Treatment for oral mucositis 

Claim​s

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

The clinical trial of OROSOL demonstrated its effectiveness in alleviating symptoms such as pain and burning sensations associated with oral mucositis, resulting in a improvement in quality of life. Additionally, OROSOL was shown to reduce the severity and grade of mucositis, lower the risk of secondary infections, minimize the formation of new ulcers, and decrease ulcer size. Furthermore, OROSOL has been proven to enhance oral hydration, contributing to improved patient well-being.

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Treatment: OROSOL®, an osmotically active hypertonic solution containing specific protease-inhibiting plant procyanidins, was sprayed over the oral mucosa 4-5 times per day for 28 days.

Mucositis Grade:

• The mean mucositis score reduced significantly in the OROSOL® group from 2.67 at the start to 0.83 on day 28, indicating nearly 70% reduction.
• In the CT group, the mean mucositis score reduced slightly from 2.33 to 2.10 on day 28, indicating a 10% reduction.

Pain Reduction:

• The mean pain intensity score in the OROSOL® group decreased from 7.19 at the start to 2.05 on day 28.
• In the CT group, the pain intensity reduced from 7.14 to 5.71.

Burning Sensation:

• The burning sensation score in the OROSOL® group reduced from 7.25 at the start to 1.92 on day 28.
• In the CT group, the burning sensation score reduced from 6.81 to 5.76.

Infection:

• The mean infection score in the OROSOL® group decreased from 2.10 at the start to 0.52 on day 28.
• In the CT group, the infection score decreased from 2.43 to 1.95.

New Ulcer Formation:

• In the OROSOL® group, new ulcer formation reduced slightly but significantly, while in the CT group, the number of ulcers remained nearly constant.

Eating Difficulty:

• The eating difficulty score in the OROSOL® group reduced from 2.81 at the start to 1.50 on day 28.
• In the CT group, the score decreased from 2.62 to 2.38.

Safety:

• OROSOL® was well-tolerated, with only slight initial burning sensation followed by salivation after application, which was temporary.

Conclusion: OROSOL® significantly reduces the severity of oral mucositis, pain, burning sensation, infection, and eating difficulty. It is a promising new therapeutic approach for treating oral mucositis.