Enrica Giammarinaro1, Saverio Cosola2, Giacomo Oldoini1, Francesco Gulia3, David Peñarrocha-Oltra4, Simone Marconcini5, Anna Maria Genovesi6. 1. Department of Stomatology, Tuscan Stomatologic Institute, Foundation for Dental Clinic, Research and Continuing Education, Forte dei Marmi, Italy. 2. Department of Stomatology, Tuscan Stomatologic Institute, Foundation for Dental Clinic, Research and Continuing Education, Forte dei Marmi, Italy; Department of Stomatology, Faculty of Medicine and Dentistry, University of Valencia, Valencia, Spain, Phone: +39 0584 605 988, e-mail: s.cosola@hotmail.it. 3. Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy. 4. Department of Stomatology, Faculty of Medicine and Dentistry, University of Valencia, Valencia, Spain. 5. Department of Stomatology, Tuscan Stomatologic Institute, Foundation for Dental Clinic, Research and Continuing Education, Forte dei Marmi, Italy; Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy. 6. Department of Stomatology, Tuscan Stomatologic Institute, Foundation for Dental Clinic, Research and Continuing Education, Forte dei Marmi, Italy; Department of Multidisciplinary Regerative Research, Guglielmo Marconi University, Rome, Italy.
Abstract
BACKGROUND: Recurrent or occasional aphthous lesions represent a painful oral condition with high prevalence. Since the etiology is still unclear and most likely related to a dysfunction in the local immune system, several treatment strategies have been proposed, including systemic agents, local agents, and laser therapy, to reduce the pain and discomfort for the patient without acting on the causes. MATERIALS AND METHODS: The purpose of the present randomized study was to assess the clinical efficacy of a new topical gel with mucoadhesive property to reduce the pain and the dimension of the aphthosis lesions. Fifty patients presenting at least one minor ulcer were randomized to a control group (placebo prescription), a first test group (topical agent with laser), and a second test group (topical agent only). The healing rate, the visual analog scale (VAS) score for pain, and the diameter reduction were monitored for 10 days. RESULTS: Both test groups showed better results than control group, significant clinical efficacy, and a median total reduction time of 4 days with no significant adjunctive benefit from the use of laser. CONCLUSION: The clinical results are encouraging; nevertheless other studies are needed to valid this kind of treatment. CLINICAL SIGNIFICANCE: The present randomized clinical study suggested that the use of topical mucoadhesive agents could represent a valid therapy for minor aphthous lesions. How to cite this article: Giammarinaro E, Cosola S, Oldoini G, et al. Local Formula with Mucoadhesive Property: A Randomized Clinical Trial of a Therapeutic Agent for the Treatment of Oral Aphthous Ulcers. J Contemp Dent Pract 2019;20(11):1249-1253.
RCT Entities:
BACKGROUND: Recurrent or occasional aphthous lesions represent a painful oral condition with high prevalence. Since the etiology is still unclear and most likely related to a dysfunction in the local immune system, several treatment strategies have been proposed, including systemic agents, local agents, and laser therapy, to reduce the pain and discomfort for the patient without acting on the causes. MATERIALS AND METHODS: The purpose of the present randomized study was to assess the clinical efficacy of a new topical gel with mucoadhesive property to reduce the pain and the dimension of the aphthosis lesions. Fifty patients presenting at least one minor ulcer were randomized to a control group (placebo prescription), a first test group (topical agent with laser), and a second test group (topical agent only). The healing rate, the visual analog scale (VAS) score for pain, and the diameter reduction were monitored for 10 days. RESULTS: Both test groups showed better results than control group, significant clinical efficacy, and a median total reduction time of 4 days with no significant adjunctive benefit from the use of laser. CONCLUSION: The clinical results are encouraging; nevertheless other studies are needed to valid this kind of treatment. CLINICAL SIGNIFICANCE: The present randomized clinical study suggested that the use of topical mucoadhesive agents could represent a valid therapy for minor aphthous lesions. How to cite this article: Giammarinaro E, Cosola S, Oldoini G, et al. Local Formula with Mucoadhesive Property: A Randomized Clinical Trial of a Therapeutic Agent for the Treatment of Oral Aphthous Ulcers. J Contemp Dent Pract 2019;20(11):1249-1253.
Authors: Mohammed Khaleel Ahmed; Mohammed Jafer; Maryam Nayeem; Ibtisam Hussain Moafa; Mir Furruq Ali Quadri; Hema Gopalaiah; Mir Faeq Ali Quadri Journal: J Multidiscip Healthc Date: 2020-11-18