Clinical Efficacy of a Topical Gel for the Treatment of Minor Oral Ulcers: A Triple-Blind Randomized Controlled Trial
Background: Recurrent aphthous stomatitis (RAS) has been recognized as a pathology characterized by ulcerations of the oral mucosa with a wide cross-prevalence in the general population. The aim of the present investigation was to investigate a new gel formulation for the treatment of minor oral ulc...
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MDPI AG
2025-06-01
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| author | Felice Lorusso Nicolai Gianluca Antonio Scarano |
| author_facet | Felice Lorusso Nicolai Gianluca Antonio Scarano |
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| description | Background: Recurrent aphthous stomatitis (RAS) has been recognized as a pathology characterized by ulcerations of the oral mucosa with a wide cross-prevalence in the general population. The aim of the present investigation was to investigate a new gel formulation for the treatment of minor oral ulcers after 2 weeks of treatment. Materials and Methods: A randomized triple-blinded controlled trial was designed for the present purpose. A total of two different study groups was conceptualized: group I (placebo) and group II (active treatment). After the enrolment process, the subjects were included in a domiciliary treatment and evaluated by a blinded operator to clinical scoring and thermography assessment at the baseline, after 1 week, and 2 weeks. Results: A total of 60 patients were observed and treated in the present study. The mean age of the patients was 34.91 ± 7.27 years old for a total of 38 females and 22 males. At 1 and 2 weeks, a significant difference in clinical scoring was observed comparing group I and group II (<i>p</i> < 0.05). A significant reduction in pain score was detected in group II patients (<i>p</i> < 0.05) after the topical gel administration. Conclusions: According to the findings of this randomized trial, the gel treatment showed a significant decrease in the signs and symptoms of oral ulcerations and could be considered useful to ameliorate the clinical course of the disease. |
| format | Article |
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| spelling | doaj-art-ad0a87d3b9c840c2bd89c9a7efdcb57b2025-07-11T14:36:26ZengMDPI AGApplied Sciences2076-34172025-06-011513734710.3390/app15137347Clinical Efficacy of a Topical Gel for the Treatment of Minor Oral Ulcers: A Triple-Blind Randomized Controlled TrialFelice Lorusso0Nicolai Gianluca1Antonio Scarano2Department of Innovative Technologies in Medicine & Dentistry, University of Chieti-Pescara, 66100 Chieti, ItalyOdontostomatology Department of Maxillo-Facial Surgery, Università di Tor Vergata, 00042 Rome, ItalyDepartment of Innovative Technologies in Medicine & Dentistry, University of Chieti-Pescara, 66100 Chieti, ItalyBackground: Recurrent aphthous stomatitis (RAS) has been recognized as a pathology characterized by ulcerations of the oral mucosa with a wide cross-prevalence in the general population. The aim of the present investigation was to investigate a new gel formulation for the treatment of minor oral ulcers after 2 weeks of treatment. Materials and Methods: A randomized triple-blinded controlled trial was designed for the present purpose. A total of two different study groups was conceptualized: group I (placebo) and group II (active treatment). After the enrolment process, the subjects were included in a domiciliary treatment and evaluated by a blinded operator to clinical scoring and thermography assessment at the baseline, after 1 week, and 2 weeks. Results: A total of 60 patients were observed and treated in the present study. The mean age of the patients was 34.91 ± 7.27 years old for a total of 38 females and 22 males. At 1 and 2 weeks, a significant difference in clinical scoring was observed comparing group I and group II (<i>p</i> < 0.05). A significant reduction in pain score was detected in group II patients (<i>p</i> < 0.05) after the topical gel administration. Conclusions: According to the findings of this randomized trial, the gel treatment showed a significant decrease in the signs and symptoms of oral ulcerations and could be considered useful to ameliorate the clinical course of the disease.https://www.mdpi.com/2076-3417/15/13/7347oral ulcersoral mucosarecurrent aphthous stomatitistopical agents |
| spellingShingle | Felice Lorusso Nicolai Gianluca Antonio Scarano Clinical Efficacy of a Topical Gel for the Treatment of Minor Oral Ulcers: A Triple-Blind Randomized Controlled Trial Applied Sciences oral ulcers oral mucosa recurrent aphthous stomatitis topical agents |
| title | Clinical Efficacy of a Topical Gel for the Treatment of Minor Oral Ulcers: A Triple-Blind Randomized Controlled Trial |
| title_full | Clinical Efficacy of a Topical Gel for the Treatment of Minor Oral Ulcers: A Triple-Blind Randomized Controlled Trial |
| title_fullStr | Clinical Efficacy of a Topical Gel for the Treatment of Minor Oral Ulcers: A Triple-Blind Randomized Controlled Trial |
| title_full_unstemmed | Clinical Efficacy of a Topical Gel for the Treatment of Minor Oral Ulcers: A Triple-Blind Randomized Controlled Trial |
| title_short | Clinical Efficacy of a Topical Gel for the Treatment of Minor Oral Ulcers: A Triple-Blind Randomized Controlled Trial |
| title_sort | clinical efficacy of a topical gel for the treatment of minor oral ulcers a triple blind randomized controlled trial |
| topic | oral ulcers oral mucosa recurrent aphthous stomatitis topical agents |
| url | https://www.mdpi.com/2076-3417/15/13/7347 |
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