Dose-ranging Study of Dentoxol® Mouthrinse for Managing Oral Symptoms in People With Epidermolysis Bullosa.

Summary

Inherited Epidermolysis Bullosa (EB) is a disorder that causes skin fragility and blistering in skin and mucous membranes, including the mouth. Recurrent oral blisters and ulcer result in oral pain and discomfort. Dentoxol® is a mouthrinse that has anti-inflammatory, antimicrobial and analgesic effects. It has significant potential to reduce EB related oral symptoms. This study includes people living with Inherited Epidermolysis Bullosa aged 6 and above; and is aimed at determining the efficacy of two different dose regimens of Dentoxol mouthrinse in reducing oral symptoms.

Timeline

Start

2022-04-06

Primary completion

2022-08

Completion

2023-03

Publications

• Background Has C, Bauer JW, Bodemer C, Bolling MC, Bruckner-Tuderman L, Diem A, Fine JD, Heagerty A, Hovnanian A, Marinkovich MP, Martinez AE, McGrath JA, Moss C, Murrell DF, Palisson F, Schwieger-Briel A, Sprecher E, Tamai K, Uitto J, Woodley DT, Zambruno G, Mellerio JE. Consensus reclassification of inherited epidermolysis bullosa and other disorders with skin fragility. Br J Dermatol. 2020 Oct;183(4):614-627. doi: 10.1111/bjd.18921. Epub 2020 Mar 11.
• Background Uitto J. Toward treatment and cure of epidermolysis bullosa. Proc Natl Acad Sci U S A. 2019 Dec 26;116(52):26147-26149. doi: 10.1073/pnas.1919347117. Epub 2019 Dec 11. No abstract available.
• Background Has C, Liu L, Bolling MC, Charlesworth AV, El Hachem M, Escamez MJ, Fuentes I, Buchel S, Hiremagalore R, Pohla-Gubo G, van den Akker PC, Wertheim-Tysarowska K, Zambruno G. Clinical practice guidelines for laboratory diagnosis of epidermolysis bullosa. Br J Dermatol. 2020 Mar;182(3):574-592. doi: 10.1111/bjd.18128. Epub 2019 Aug 9.
• Background Korolenkova MV. [Dental treatment in children with dystrophic form of epidermolysis bullosa]. Stomatologiia (Mosk). 2015;94(2):34-36. doi: 10.17116/stomat201594234-36. Russian.
• Background Puliyel D, Chiu CH, Habibian M. Restorative and periodontal challenges in adults with dystrophic epidermolysis bullosa. J Calif Dent Assoc. 2014 May;42(5):313-8.
• Background Mello BZ, Neto NL, Kobayashi TY, Mello MB, Ambrosio EC, Yaedu RY, Machado MA, Oliveira TM. General anesthesia for dental care management of a patient with epidermolysis bullosa: 24-month follow-up. Spec Care Dentist. 2016 Jul;36(4):237-40. doi: 10.1111/scd.12170. Epub 2016 Mar 2.
• Background Pekiner FN, Yucelten D, Ozbayrak S, Sezen EC. Oral-clinical findings and management of epidermolysis bullosa. J Clin Pediatr Dent. 2005 Fall;30(1):59-65. doi: 10.17796/jcpd.30.1.y503845545kn78x7.
• Background Oliveira TM, Sakai VT, Candido LA, Silva SM, Machado MA. Clinical management for epidermolysis bullosa dystrophica. J Appl Oral Sci. 2008 Jan-Feb;16(1):81-5. doi: 10.1590/s1678-77572008000100016.
• Background Kummer TR, Nagano HC, Tavares SS, Santos BZ, Miranda C. Oral manifestations and challenges in dental treatment of epidermolysis bullosa dystrophica. J Dent Child (Chic). 2013 May-Aug;80(2):97-100.
• Background Marini I, Vecchiet F. Sucralfate: a help during oral management in patients with epidermolysis bullosa. J Periodontol. 2001 May;72(5):691-5. doi: 10.1902/jop.2001.72.5.691.
• Background Fortuna G, Lozada-Nur F, Pollio A, Aria M, Cepeda-Valdes R, Marinkovich MP, Bruckner AL, Salas-Alanis JC. Patterns of oral mucosa lesions in patients with epidermolysis bullosa: comparison and agreement between oral medicine and dermatology. J Oral Pathol Med. 2013 Nov;42(10):733-40. doi: 10.1111/jop.12094. Epub 2013 Jun 15.
• Background Fortuna G, Aria M, Cepeda-Valdes R, Pollio A, Moreno-Trevino MG, Salas-Alanis JC. Clinical features of gingival lesions in patients with dystrophic epidermolysis bullosa: a cross-sectional study. Aust Dent J. 2015 Mar;60(1):18-23. doi: 10.1111/adj.12264.
• Background Brun J, Chiaverini C, Devos C, Leclerc-Mercier S, Mazereeuw J, Bourrat E, Maruani A, Mallet S, Abasq C, Phan A, Vabres P, Martin L, Bodemer C, Lagrange S, Lacour JP; Research Group of the French Society of Pediatric Dermatology. Pain and quality of life evaluation in patients with localized epidermolysis bullosa simplex. Orphanet J Rare Dis. 2017 Jun 28;12(1):119. doi: 10.1186/s13023-017-0666-5.
• Background Stellingsma C, Dijkstra PU, Dijkstra J, Duipmans JC, Jonkman MF, Dekker R. Restrictions in oral functions caused by oral manifestations of epidermolysis bullosa. Eur J Dermatol. 2011 May-Jun;21(3):405-9. doi: 10.1684/ejd.2011.1356.
• Background Wright JT. Comprehensive dental care and general anesthetic management of hereditary epidermolysis bullosa. A review of fourteen cases. Oral Surg Oral Med Oral Pathol. 1990 Nov;70(5):573-8. doi: 10.1016/0030-4220(90)90401-d.
• Background Cheng KK. Children's acceptance and tolerance of chlorhexidine and benzydamine oral rinses in the treatment of chemotherapy-induced oropharyngeal mucositis. Eur J Oncol Nurs. 2004 Dec;8(4):341-9. doi: 10.1016/j.ejon.2004.04.002.
• Background Sindici E, Astesano S, Fazio L, Dragonetti A, Pugliese M, Scully C, Carossa S, Broccoletti R, Arduino PG. Treatment of Oral Lesions in Dystrophic Epidermolysis Bullosa: A Case Series of Cord Blood Platelet Gel and Low-level Laser Therapy. Acta Derm Venereol. 2017 Mar 10;97(3):383-384. doi: 10.2340/00015555-2512. No abstract available.
• Background Kramer S, Lucas J, Gamboa F, Penarrocha Diago M, Penarrocha Oltra D, Guzman-Letelier M, Paul S, Molina G, Sepulveda L, Araya I, Soto R, Arriagada C, Lucky AW, Mellerio JE, Cornwall R, Alsayer F, Schilke R, Antal MA, Castrillon F, Paredes C, Serrano MC, Clark V. Clinical practice guidelines: Oral health care for children and adults living with epidermolysis bullosa. Spec Care Dentist. 2020 Nov;40 Suppl 1(Suppl 1):3-81. doi: 10.1111/scd.12511.
• Background Lalla RV, Sole S, Becerra S, Carvajal C, Bettoli P, Letelier H, Santini A, Vargas L, Cifuentes A, Larsen F, Jara N, Oyarzun J, Feinn R, Bustamante E, Martinez B, Rosenberg D, Galvan T. Efficacy and safety of Dentoxol(R) in the prevention of radiation-induced oral mucositis in head and neck cancer patients (ESDOM): a randomized, multicenter, double-blind, placebo-controlled, phase II trial. Support Care Cancer. 2020 Dec;28(12):5871-5879. doi: 10.1007/s00520-020-05358-4. Epub 2020 Apr 8.
• Rojas P, Kramer S, Veliz S, Seguel M, Alsayer F, Sepulveda L. Dentoxol Mouthwash for People With Epidermolysis Bullosa: A Qualitative Study of Self-Perceived Symptoms and Quality of Life. Spec Care Dentist. 2025 Mar-Apr;45(2):e70036. doi: 10.1111/scd.70036.

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