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EP-4739332-A1 - ORAL CARE COMPOSITIONS FOR USE IN THE TREATMENT OF DENTAL HEALTH CONDITIONS

EP4739332A1EP 4739332 A1EP4739332 A1EP 4739332A1EP-4739332-A1

Abstract

The present invention relates to polymer strips and compositions for use in oral care and various methods of their use. In particular, it relates to compositions comprising phosphoproteins and their use in the treatment and prevention of bleeding gums and the treatment and prevention of periodontal disease. Preferred compositions comprise osteopontin and derivatives thereof.

Inventors

  • WILLSON, RICHARD
  • SMILLIE, David
  • RAFFERTY, Carol

Assignees

  • Dentherapy Ltd

Dates

Publication Date
20260513
Application Date
20240704

Claims (20)

  1. Claims: 1. A composition comprising a phosphopeptide for use in the prevention or treatment of periodontal disease in a subject in need thereof.
  2. 2. A composition comprising a phosphopeptide for use in the prevention or treatment of bleeding gums in a subject in need thereof.
  3. 3. The composition for use according to claim 2, wherein bleeding gums are associated with the use of orthodontic devices, fixed or removable dental prosthesis and/or dental implants.
  4. 4. The composition for use according to claim 3, wherein orthodontic devices comprise orthodontic aligners or fixed orthodontic brackets.
  5. 5. The composition for use according to claim 2, wherein bleeding gums are associated with or caused by periodontal disease.
  6. 6. The composition for use according to any one of claims 1 or 5, wherein the periodontal disease is gingivitis or periodontitis.
  7. 7. The composition for use according to claim 6, wherein gingivitis is characterised as localised gingivitis or generalised gingivitis.
  8. 8. The composition for use according to any one of claims 1, 5 or 6, wherein periodontitis is stage I, stage II, stage III, or stage IV periodontitis.
  9. 9. The composition for use according to any one of claims 1 or 5-8, wherein the composition is for use in treating or preventing established periodontal disease.
  10. 10. The composition for use according to any one of claims 1 or 5-9, wherein the composition is for use in preventing the progression of gingivitis to periodontitis in a subject with periodontal disease.
  11. 11. A composition comprising a phosphopeptide for use in the prevention or treatment of peri-implant mucositis and/or peri-implantitis in a subject in need thereof.
  12. 12. A method of treating or preventing bleeding gums in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of a composition comprising a phosphopeptide.
  13. 13. A method of treating or preventing periodontal disease in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of a composition comprising a phosphopeptide.
  14. 14. A method of treatment or prevention of peri-implant mucositis and/or peri-implantitis in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of a composition comprising a phosphopeptide.
  15. 15. The composition for use according to any one of claims 1-11 or the method according to any one of claims 12-14, wherein the subject is a non-responder to conventional therapy.
  16. 16. A composition for use according to any one of claims 1-11 and 15 or the method according to any one of claims 12-15, wherein the composition does not comprise additional phosphate or an additional source of phosphate.
  17. 17. A composition for use according to any one of claims 1-11 or 15 or the method according to any one of claims 12-15 wherein the composition does not comprise a phosphate buffer.
  18. 18. A composition for use according to any one of claims 1-11 and 15-17 or the method according to any one of claims 12-17 wherein the phosphopeptide comprises osteopontin or phosphopeptides derived therefrom, and/or casein or phosphopeptides derived therefrom, preferably wherein phosphopeptide is OPN-10.
  19. 19. A composition for use according to any one of claims 1-11, 15-16 and 18 or the method according to any one of claims 12-16 and 18, wherein the composition comprises less than 50mM phosphate.
  20. 20. A composition for use according to any one of claims 1-11 and 15-19 or the method according to any one of claims 12-19 wherein the composition further comprises fluoride or a source of fluoride, preferably the source of fluoride is monofluorophosphate.

Description

ORAL CARE COMPOSITIONS FOR USE IN THE TREATMENT OF DENTAL HEALTH CONDITIONS The present invention relates to compositions for use in oral care and various methods of their use. More particularly, the invention relates to compositions comprising phosphoproteins and their use in the treatment and prevention of periodontal disease, in particular gingivitis and periodontitis. Background of the Invention The following discussion is provided to aid the reader in understanding the disclosure and does not constitute any admission as to the contents or relevance of the prior art. Periodontal disease is one of the most prevalent diseases worldwide, with an estimated 20- 50% of the global population experiencing some form of periodontal disease [1]. This not only results in significant dental health challenges but there is also substantial evidence that shows periodontal disease increases the risk of systemic inflammatory conditions such as cardiovascular disease and diabetes mellitus. Periodontal disease is the general description applied to the inflammatory response of the gingiva and surrounding connective tissue to bacterial plaque accumulations on the teeth at the gingival margin. The inflammatory response can be divided into two general groupings: gingivitis and periodontitis. Gingivitis is extremely common and is associated with the accumulation of supragingival plaque along the gingival margins of the teeth. Gingivitis clinically manifests as bleeding of the gingival or gum tissues without evidence of bone loss or periodontal pocket formation. At this stage, gingivitis is a reversable inflammatory stage of periodontal disease and may be mitigated by good oral hygiene and removal of bacterial biofilm. However, if left untreated, the condition may progress to periodontitis, as characterised by permanent periodontal tissue loss. Periodontitis occurs when the inflammatory response in the tissue results in loss of collagen, periodontal ligament attachment of the tooth to the bone, loss of alveolar bone, and development of periodontal pockets. Periodontal pockets provide an environment for pathogenic bacteria to proliferate further. Untreated periodontitis can eventually lead to tooth loss. The initial colonizers of the teeth are Streptococci species, which proliferate and in turn become colonized by other bacteria present in saliva, such as various Actinomyces species and Veillonella species. The greatest growth of the plaque occurs at the gingival margin, where plaque accumulations usually are visible after several days. Dysbiosis of the subgingival microbiome adversely affects the host immune system, creating and maintaining unmitigated inflammation in gingival and periodontal tissues. The recruitment of immune cells and the production of several inflammatory mediators contribute to tissue damage and tooth loss. This persistent inflammation prevents immune subversion and tissue recovery, which not only results in local chronic inflammation in the mouth but also increases the risk of systemic disease such as cardiovascular disease, diabetes mellitus, Alzheimer’s disease, and cancer [1, 2]. No longer can periodontal diseases be considered simple bacterial infections. Rather, they are complex diseases of multifactorial nature involving an intricate interplay between the subgingival microbiota, the host immune and inflammatory responses, and environmental modifying factors. Thus, periodontal health must not be considered solely in the context of plaque/bacteria levels and control but must embrace a holistic consideration and evaluation of all factors responsible for the emergence of disease [3]. Current treatments for periodontal disease include minimising biofilm accumulation on tooth surfaces which is currently achieved by mechanical cleaning and antimicrobial agents. Antimicrobial agents seek to kill pathogenic bacteria in dental biofilms, but they also affect commensal microorganisms on soft tissues that contribute to microbial homeostasis. The indiscriminate killing of these commensal bacteria may lead to a disequilibrium in the oral microbiota and a higher risk of developing systemic inflammatory diseases. Moreover, patients with chronic periodontitis have to remain on strict dental maintenance program, with regular visits to the dental health care provider to help maintain periodontal stability and minimise further attachment loss. About 20 to 30% of all chronic periodontitis cases do not respond favourably to conventional periodontal treatment. Many factors may contribute to such responses, such as improper removal of bacterial deposits, poor plaque control, smoking, and systemic conditions such as diabetes mellitus that may lead to an impaired immune response. These factors are not always readily identifiable and may not be modifiable or properly controlled. It will be understood that host determinant factors of clinical periodontology may include but are not limited to the following: Localised Risk Factor