Search

EP-4740952-A1 - ASSOCIATION OF GASEOUS MOLECULAR OXYGEN AND HYALURONIC ACID FOR USE IN THE TREATMENT OF INFLAMMATORY CONDITIONS AND/OR LESIONS OF THE ORAL CAVITY

EP4740952A1EP 4740952 A1EP4740952 A1EP 4740952A1EP-4740952-A1

Abstract

The present invention relates to an oral topical association comprising: molecular oxygen characterized by a degree of purity ≥ 90% by volume (v/v), and hyaluronic acid comprised in a formulation comprising suitable excipients and/or diluents, and which does not comprise molecular oxygen, for use in the treatment of inflammatory states of the oral cavity and/or continuous lesions of the oral cavity.

Inventors

  • Montanari, Federico
  • Garoia, Flavio

Assignees

  • Caress Flow S.r.l.

Dates

Publication Date
20260513
Application Date
20251107

Claims (9)

  1. Oral topical association comprising - molecular oxygen characterized by a degree of purity ≥ 90% by volume (v/v), and - hyaluronic acid comprised in a formulation containing suitable excipients and/or diluents, and which does not comprise molecular oxygen, for use in the treatment of inflammatory states of the oral cavity and/or continuous lesions of the oral cavity.
  2. Association for use according to claim 1, wherein the inflammatory states of the oral cavity manifest concurrently with or are caused by conditions selected from the group consisting of: thermal or mechanical stresses or traumas or, further, induced by irritating substances; surgical interventions; dental plaque accumulation; reduced immune defences; pathogens; inflammatory diseases of the oral cavity; lesions of the oral cavity; and combinations of the foregoing.
  3. Association for use according to claim 1 or 2, wherein the inflammatory diseases of the oral cavity are selected from the group consisting of: gingivitis; periodontitis; periodontal disease; and combinations of the foregoing.
  4. Association for use according to any one of claims 1 to 3, wherein the molecular oxygen dosage is comprised between 0.1 and 130 litres.
  5. Association for use according to any one of claims 1 to 4, wherein the formulation, comprising the hyaluronic acid, is in a liquid or semi-solid formulation.
  6. Association for use according to any one of claims 1 to 5, wherein the hyaluronic acid is comprised in the formulation in an amount comprised between 0.01% and 5% by weight on the total weight of the formulation.
  7. Association for use according to claim 5 or 6, wherein the hyaluronic acid is the only active ingredient comprised in the formulation.
  8. Association for use according to any of claims 1 to 7, wherein the continuous lesions of the oral cavity are lesions/wounds that occur in conjunction with or are caused by conditions selected from the group consisting of: thermal or mechanical trauma or stress; surgical interventions; pathogens; inflammatory diseases; and combinations of the foregoing.
  9. Kit comprising • the association for use according to any one of claims 1 to 8, • means for delivering the molecular oxygen and means for applying the hyaluronic acid at oral topical level, preferably at least one cannula and/or spray gun.

Description

FIELD OF THE INVENTION The present patent application relates to an association of molecular or gaseous oxygen and hyaluronic acid for use in the dental field, specifically for use in the treatment of inflammatory states and/or continuous lesions of the oral cavity. STATE OF THE ART The oral cavity or mouth is the entry point of the digestive and respiratory systems. In humans, the mouth is defined anteriorly by the lips, laterally by the cheeks, posteriorly by the pharynx, superiorly by the palate, inferiorly by a muscular floor, stretched inside the arch formed by the mandible, or lower jaw. The following can be distinguished: anteriorly the vestibule, delimited posteriorly by the dental arches and by the lips;the oral cavity proper with the sublingual sulcus inferiorly, which is entirely occupied by the tongue when the mouth is closed;the pharynx, also called the isthmus of the fauces, identified anteriorly by a plane passing along the posterior margin of the palatopharyngeus muscle. The oral cavity can be partially or totally affected by an inflammatory state that can affect the epithelium and the mucous membranes and which manifests with burning, swelling, inflammation of the mouth and formation of lesions. The inflammation of the oral cavity can involve the soft parts of the mouth, such as the mucous membranes that line the gums, the inside of the cheeks, the palate, the inner surface of the lips and the tongue. The inflammation of the epithelium and/or the oral mucosa can be localized in a specific point (gums, lips, palate, tongue) or be generalized to the entire cavity. It can have an acute onset and resolve in a few weeks or become a chronic condition. Oral inflammation can, for example, be caused by the accumulation of dental plaque which, if neglected, can generate an inflammatory reaction that initially manifests on the adjacent gums. The microorganisms that make up the plaque are usually harmless in the mouth; however, poor oral hygiene, a diet rich in sugars, a decrease in immune defences and systemic diseases can alter the environment of the mouth and make the microorganisms harmful. Other factors that contribute to causing inflammation of the mouth are represented by mechanical traumas - caused by orthodontic appliances or unsuitable or unstable dental prostheses; surgical interventions - irritating substances, such as tobacco and spices, alcohol consumption, vitamin or iron deficiencies, allergic reactions, anxiety or stress. Finally, caries, intoxications, hormonal or metabolic dysfunctions and prolonged treatments with particular drugs can contribute to the degeneration of the inflammatory process. As mentioned, the inflammatory process can also occur in the context of lesions that can be present at the level of the oral epithelium and/or oral mucosa. In particular, the healing or re-epithelialization of oral lesions is a complex and dynamic process that involves the repair of cellular structures and tissue layers. This process is divided into several interconnected phases: inflammation, re-epithelialization, granulation tissue formation, matrix formation and tissue remodelling. Re-epithelialization is a crucial step, which involves the interaction between keratinocytes and the extracellular matrix, allowing the migration, proliferation and differentiation of cells, with the restoration of the structure and function of the tissue. It is widely recognized that the initial phase of healing, immediately after a surgical intervention, has a decisive influence on clinical outcomes. Therefore, an adequate postoperative protocol is essential to ensure an optimal environment for healing and to maximize clinical outcomes, especially after periodontal or implant procedures. An adequate level of oxygen is important for optimal wound healing. Hypoxia inhibits the healing process, for example by blocking the release of growth factors and angiogenesis, while oxygen is necessary to support this process. One of the therapeutic options that can sometimes counteract the effects of tissue hypoxia is oxygen therapy (Rodriguez PG, Felix FN, Woodley DT, Shim EK (2008). The role of oxygen in wound healing: a review of the literature. Dermatol Surg 34:1159-1169). Starting from the 1960s, various forms of oxygen therapy for wound healing have been developed, such as hyperbaric oxygen therapy (HBOT) and topical oxygenation (TOT), with significant evidence of their benefits. In the treatment of hypoxic and ischemic wounds, the HBOT has been shown to stimulate fibroblast proliferation, collagen formation and cross-linking, and neovascularization. Furthermore, it has an antibacterial effect thanks to the stimulation of leukocytes and the production of reactive oxygen species (ROS). This type of oxygen therapy can also modulate the activity of cytokines and other inflammatory mediators, reducing tissue damage and containing infections. Ischemic soft tissues benefit from hyperoxygenation thanks to a better preservatio