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OROSOL : treatment for oral mucositis


OROSOL is an innovative 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 in as little as 20 minutes. Clinical results show continued improvement with regular use, offering patients long-lasting relief and improved quality of life.

Clinical trial

Randomized, double-blind, placebo-controlled trial

Population

This product is intended for adult use

Indication

Treatment of oral mucositis induced by radio or chemotherapy

Overview


OROSOL is a revolutionary product designed to provide relief and treatment for oral mucositis induced by radiotherapy or chemotherapy. This throat spray, presented in a 20ml bottle, targets pro-inflammatory proteins, contaminants, and impurities, offering a threefold action for optimal results.


Mode of action


Protective Barrier Effect:

MucositisOROSOL creates a protective barrier in the oral cavity, shielding the mucous membranes from further damage and allowing the healing process to begin.

 

Osmotic and Cleaning Effect:

The product works to cleanse the oral cavity, removing impurities and contaminants that can exacerbate inflammation and delay healing.

 

Cellular Repair and Growth Effect:

MucositisOROSOL promotes the repair and growth of cells in the oral cavity, accelerating the healing process and reducing the duration of symptoms.

 



Clinical Trial


Participants: The study included 69 patients with oral mucositis, with 48 in the OROSOL® group and 21 in the classical treatment (CT) group. Patients were between the ages of 7 and 91 years, with a mean age of 54.68 years.

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 of multiple origins



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Product Details


  • Indication: Filmogen liquid bandage for the treatment of oral mucositis induced by radiotherapy or chemotherapy.
  • Composition: Filmogenic glycerol, honey, water, association of Vaccinium macrocarpon and Vaccinium myrtillus.
  • Presentation: Throat spray 20ml.
  • Class: MDR Class IIa.
  • Direction: Apply 2 sprays in the throat, 2-3 times a day.
  • Precautions: For topical use only (oral cavity). Keep out of reach and sight of children.
  • Age: 18+.
  • Storage conditions: Below 25°C.
  • Legal manufacturer: VITROBIO (France).
  • Product code: OS.