Abstract
This chapter discusses the opportunities offered by medical devices as supportive care for oromucosal pathologies. There are still many unmet needs in the treatment of these pathologies, one such example is oral mucositis caused by cancer chemo-radiotherapy. This condition does not have a satisfactory treatment at the present time, yet it is so disabling to the patient that it may eventually lead to the discontinuation of cancer therapy.
After a brief introduction that includes definitions and relevant regulations, the oral conditions that can be treated with a medical device are considered, in particular mucositis, aphthae and xerostomia. In addition the mechanisms of action by which medical devices function are reviewed and a list of representative products available on the markets is included in the chapter. In the last section the results of authors’ ongoing research aimed at developing new improved class II medical devices are presented. These studies are currently focused on the development of suitable mucoadhesive vehicles (gels and in situ gelling spray), to be extemporaneously reconstituted with appropriate drugs or drug products, that are capable of assuring a prolonged contact with the damaged mucosa and prevent the detrimental removal effect of biological fluids.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsReferences
Abelson DC, Barton J, Mandel ID (1989) Effect of sorbitol sweetened breath mints on salivary flow and plaque pH in xerostomic subjects. J Clin Dent 1:102–105
Alajbeg I, Falcão DP, Tran SD, Martín-Granizo R, Lafaurie GI, Matranga D, Pejda S, Vuletić L, Mantilla R, Leal SC, Bezerra AC, Ménard HA, Kimoto S, Pan S, Maniegas L, Krushinski CA et al (2012) Oral medicine: intraoral electrostimulator for xerostomia relief: a long-term, multicenter, open-label, uncontrolled, clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol 113:773–781
Ami S, Wolff A (2010) Implant-supported electrostimulating device to treat xerostomia: a preliminary study. Clin Implant Dent Relat Res 12:62–71
Burgalassi S, Panichi L, Saettone MF, Jacobsen J, Rassing MR (1996) Development and in vitro/in vivo testing of mucoadhesive buccal patches releasing benzydamine and lidocaine. Int J Pharm 133:1–7
Caramella CM, Bonferoni MC, Rossi S, Sandri G, Ferrari F, Perotti C, Del Fante C (2011) Platelet lysate and bioadhesive compositions thereof for the treatment of mucositis. Biomed Device s.r.l. US2011/0280952 A1. Accessed 17 Nov 2011
Caramella CM, Sandri G, Rossi S, Mori M, Bonferoni MC, Ferrari F, Del Fante C, Perotti C (2013) New therapeutic platforms for the treatment of epithelial and cutaneous lesions. Curr Drug Deliv 10:18–31
Cohen S, Lobel E, Trevgoda A, Peled Y (1997) A novel in situ-forming ophthalmic drug delivery system from alginates undergoing gelation in the eye. J Control Rel 44: 201–208
D’Andrea N, Giorgiutti E, De Cordi D, Piga A (2003) Oral pharyngeal mucositis: Nursing assessment on the efficacy of a new treatment. Ann Oncol 14 (suppl 4): iv97
Dauncey J, Greedy J, Morgan K (2012) Prevention and management of treatment-related oral mucositis. Canc Nurs Pract 11:23–28
Davies A, Hall S (2011) Salivary gland dysfunction (dry mouth) in patients with advanced cancer. Int J Palliat Nurs 17:477–482
De Cordi D et al (2001) Presented at the Italian Anti Tumor League III Congress of Professional Oncology Nurses Conegliano, Oct 10–12
Del Fante C Perotti C Bonferoni MC Rossi S Sandri G Ferrari F Scudeller L Caramella C (2011) Platelet lysate mucohadesive formulation to treat oral mucositis in graft versus host disease patients: a new therapeutic approach. AAPS Pharm Sci Tech 12:893–899
Desbrières J, Hirrien M, Ross-Murphy SB (2000) Thermogelation of methylcellulose: rheological considerations. Polymers 41:2451–2461
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Eaton LH, Tipton JM (Eds) (2009) Mucositis. In: Putting Evidence Into Practice: Improving oncology patient outcomes. Pittsburgh, PA: Oncology Nursing Society, pp. 193–213
Epstein JB, Stevenson-Moore P (1992) A clinical comparative trial of saliva substitutes in radiation-induced salivary gland hypofunction. Spec Care Dentist 12:21–23
Epstein JB, Emerton S, Le ND, Stevenson-Moore P (1999) A double-blind crossover trial of Oral Balance gel and Biotene® toothpaste versus placebo in patients with xerostomia following radiation therapy. Oral Oncol 35:132–137
FDA. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm. Accessed April 2013
Ivan A, Denise PF, Simon DT et al (2012). Oral medicine: intraoral electrostimulator for xerostomia relief: a long-term, multicenter, open-label, uncontrolled, clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol. 113:773–781
Jensen SB, Pedersen AM, Vissink A et al (2010) A systematic review of salivary gland hypofunction and xerostomia induced by cancer therapies: management strategies and economic impact. Support Care Cancer 18:1061–1079
Lafaurie G, Fedele S, López RM, Wolff A, Strietzel F, Porter SR, Konttinen YT (2009) Biotechnological advances in neuro-electro-stimulation for the treatment of hyposalivation and xerostomia. Med Oral Patol Oral Cir Bucal 14:E76–80
Lalla RV, Keefe DMK (2010) Mucositis (oral mucositis). In: Olver Ian N (ed) The MASCC textbook of cancer supportive care and survivorship. Springer: US, pp 241–248
Lindsay G (2009) The clinical effectiveness of Gelclair in the management of oral mucositis. Aust Nurs J 16:30–33
McKenzie M, Papish S, Hansen VA (2006) Randomized open label trial comparing Gelclair with institutional standard magic mouthwash for the treatment of pain associated with radiation or chemotherapy induced mucositis. Support Cancer Care 14:641
McMillan AS, Tsang CS, Wong MC, Kam AY (2006) Efficacy of a novel lubricating system in the management of radiotherapy-related xerostomia. Oral Oncol 42:842–848
Naidu MU, Ramana GV, Ratnam SV, Sudhavani T, Naidu KJ, Roy P, Suresh P, Rani PU, Mohan IK (2005) A randomised, double-blind, parallel, placebo-controlled study to evaluate the efficacy of MF 5232 (Mucotrol), a concentrated oral gel wafer, in the treatment of oral mucositis. Drugs RD 6: 291–298
Nakamoto RY (1979) Use of a saliva substitute in postradiation xerostomia. J Prosthet Dent 42:539–542
Ownby HE (1982) Use of a saliva substitute in postradiation xerostomic patients. Ky Dent J 34:22–24
Pettit L, Davis G, Sanghera P, Whitmarsh S, Hartley A (2011) The use of Mugard & Caphosol in patients with locally advanced squamous cell carcinoma of the head and neck. Radiother Oncol 98:S25
Preeti L, Magesh KT, Raikumar K, Karthik R (2011) Recurrent aphtous stomatitis. J Oral Maxillofac Pathol 15:252–256
Regelink G, Vissink A, Reintsema H, Nauta JM (1998) Efficacy of a synthetic polymer saliva substitute in reducing oral complaints of patients suffering from irradiation-induced xerostomia. Quintessence Int 29:383–388
Rodríguez-Caballero A., Torres-Lagares D., Robles-García M., Pachón-Ibáñez J., González-Padilla D., Gutiérrez-Pérez J.L. (2012) Cancer treatment-induced oral mucositis: a critical review. Int J Oral Maxillofac Surg 41:225–238
Rossi S, Marciello M, Bonferoni MC, Ferrari F, Sandri G, Dacarro C, Grisoli P, Caramella C (2010) Thermally sensitive gels based on chitosan derivatives for the treatment of oral mucositis. Eur J Pharm Biopharm 74:248–254
Ruel-Gariépy E, Leroux J-C. In situ-forming hydrogels—review of temperature-sensitive systems. Eur J Pharm Biopharm 2004a;58:409–26
Ruel-Gariépy E, Shive M, Bichar A, et al (2004b) A thermosensitive chitosan-based hydrogel for the local delivery of paclitaxel. Eur J Pharm Biopharm 57:53–63
Salamat-Miller N, Chittchang M, Johnston TP (2005) The use of mucoadhesive polymers in buccal drug delivery. Adv Drug Del Syst 57:1666–1691
Sandri G, Bonferoni MC, Ferrari F, Rossi S, Del Fante C, Perotti C, Gallanti A, Caramella C (2011a) An in situ gelling buccal spray containing platelet lysate for the treatment of oral mucositis. Curr Drug Disc Technol 8:277–285
Sandri G, Bonferoni MC, Rossi S, Ferrari F, Mori M, Del Fante C, Perotti C, Scudeller L, Caramella C (2011b) Platelet lysate formulations based on mucoadhesive polymers for the treatment of corneal lesions. J Pharm Pharmacol 63:189–198
Sandri G, Rossi S, Bonferoni MC, Ferrari F, Mori M, Caramella C (2012) The role of chitosan as a mucoadhesive agent in mucosal drug delivery. J Drug Del Sci Tech 22:275–284
Sarkar N (1995) Kinetics of thermal gelation of methylcellulose and hydroxypropylmethylcellulose in aqueous solutions. Carbohyd Polym 26:195–203
Scully C, Sonis S, Diz PD (2006) Oral mucositis. Oral Dis 12:229–241
Sonis ST (2013) Oral Mucositis. Springer Science and Business, New York
Strietzel FP, Lafaurie GI, Mendoza GRB et al (2011) Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: A multicenter, randomized trial. Arthritis Rheum 63:180–190
Vissink A, s-Gravenmade EJ, Panders AK, Vermey A, Petersen JK, Visch LL et al (1983) A clinical comparison between commercially available mucin- and CMC-containing saliva substitutes. Int J Oral Surg 12:232–238
Warde P, Kroll B, O’Sullivan B, Aslanidis J, Tew-George E, Waldron J et al (2000) A phase II study of Biotene in the treatment of ostradiation xerostomia in patients with head and neck cancer. Support Care Cancer 8:203–208
Yamamoto K, Nagashima H, Yamachika S, Hoshiba D, Yamaguchi K, Yamada H, Saito I, Nakagawa Y (2008) The application of a night guard for sleep-related xerostomia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 106: e11–e14.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2015 Controlled Release Society
About this chapter
Cite this chapter
Caramella, C. et al. (2015). Medical Devices for Oral Mucosal Applications. In: Rathbone, M., Senel, S., Pather, I. (eds) Oral Mucosal Drug Delivery and Therapy. Advances in Delivery Science and Technology. Springer, Boston, MA. https://doi.org/10.1007/978-1-4899-7558-4_10
Download citation
DOI: https://doi.org/10.1007/978-1-4899-7558-4_10
Published:
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4899-7557-7
Online ISBN: 978-1-4899-7558-4
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)