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Efficacy and Long-Term Safety of Ibuprofen Gargle for Oral Lichen Planus: A Study Protocol of Randomized Crossover and Long-Term Extension Trials

Oral lichen planus (OLP) is a type of chronic and refractory stomatitis characterized by abnormal keratinization, which is often painful. There is no consensus regarding treatment options for OLP, particularly in the presence of pain. The current study protocol focuses on the short-term efficacy and...

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Autores principales: Kitahiro, Yumi, Ioroi, Takeshi, Kakei, Yasumasa, Yamashita, Junya, Kimoto, Akira, Hasegawa, Takumi, Morioka, Asami, Yamamoto, Kazuhiro, Akashi, Masaya, Yano, Ikuko
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844393/
https://www.ncbi.nlm.nih.gov/pubmed/36648956
http://dx.doi.org/10.3390/mps6010007
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author Kitahiro, Yumi
Ioroi, Takeshi
Kakei, Yasumasa
Yamashita, Junya
Kimoto, Akira
Hasegawa, Takumi
Morioka, Asami
Yamamoto, Kazuhiro
Akashi, Masaya
Yano, Ikuko
author_facet Kitahiro, Yumi
Ioroi, Takeshi
Kakei, Yasumasa
Yamashita, Junya
Kimoto, Akira
Hasegawa, Takumi
Morioka, Asami
Yamamoto, Kazuhiro
Akashi, Masaya
Yano, Ikuko
author_sort Kitahiro, Yumi
collection PubMed
description Oral lichen planus (OLP) is a type of chronic and refractory stomatitis characterized by abnormal keratinization, which is often painful. There is no consensus regarding treatment options for OLP, particularly in the presence of pain. The current study protocol focuses on the short-term efficacy and long-term safety of an ibuprofen gargle for pain management in patients with OLP. Patients (n = 24) with painful OLP will be enrolled. During a crossover study period, patients in the ibuprofen–placebo (IP) group will receive an ibuprofen gargle (0.6%) on day 1, a placebo gargle on day 2, and an ibuprofen gargle on days 3–5 at least once daily. Patients in the placebo–ibuprofen (PI) group will receive a placebo gargle on day 1, an ibuprofen gargle on day 2, and an ibuprofen gargle on days 3–5 at least once daily. The primary endpoint of the crossover study period is the change in pain level as measured by a visual analogue scale score from before gargle administration to 5 min after gargle administration on days 1 and 2. The primary endpoint of the long-term extension study is assessment of long-term safety. The results of this study may support existing evidence regarding the effectiveness of ibuprofen rinses in treating OLP.
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spelling pubmed-98443932023-01-18 Efficacy and Long-Term Safety of Ibuprofen Gargle for Oral Lichen Planus: A Study Protocol of Randomized Crossover and Long-Term Extension Trials Kitahiro, Yumi Ioroi, Takeshi Kakei, Yasumasa Yamashita, Junya Kimoto, Akira Hasegawa, Takumi Morioka, Asami Yamamoto, Kazuhiro Akashi, Masaya Yano, Ikuko Methods Protoc Protocol Oral lichen planus (OLP) is a type of chronic and refractory stomatitis characterized by abnormal keratinization, which is often painful. There is no consensus regarding treatment options for OLP, particularly in the presence of pain. The current study protocol focuses on the short-term efficacy and long-term safety of an ibuprofen gargle for pain management in patients with OLP. Patients (n = 24) with painful OLP will be enrolled. During a crossover study period, patients in the ibuprofen–placebo (IP) group will receive an ibuprofen gargle (0.6%) on day 1, a placebo gargle on day 2, and an ibuprofen gargle on days 3–5 at least once daily. Patients in the placebo–ibuprofen (PI) group will receive a placebo gargle on day 1, an ibuprofen gargle on day 2, and an ibuprofen gargle on days 3–5 at least once daily. The primary endpoint of the crossover study period is the change in pain level as measured by a visual analogue scale score from before gargle administration to 5 min after gargle administration on days 1 and 2. The primary endpoint of the long-term extension study is assessment of long-term safety. The results of this study may support existing evidence regarding the effectiveness of ibuprofen rinses in treating OLP. MDPI 2023-01-10 /pmc/articles/PMC9844393/ /pubmed/36648956 http://dx.doi.org/10.3390/mps6010007 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Protocol
Kitahiro, Yumi
Ioroi, Takeshi
Kakei, Yasumasa
Yamashita, Junya
Kimoto, Akira
Hasegawa, Takumi
Morioka, Asami
Yamamoto, Kazuhiro
Akashi, Masaya
Yano, Ikuko
Efficacy and Long-Term Safety of Ibuprofen Gargle for Oral Lichen Planus: A Study Protocol of Randomized Crossover and Long-Term Extension Trials
title Efficacy and Long-Term Safety of Ibuprofen Gargle for Oral Lichen Planus: A Study Protocol of Randomized Crossover and Long-Term Extension Trials
title_full Efficacy and Long-Term Safety of Ibuprofen Gargle for Oral Lichen Planus: A Study Protocol of Randomized Crossover and Long-Term Extension Trials
title_fullStr Efficacy and Long-Term Safety of Ibuprofen Gargle for Oral Lichen Planus: A Study Protocol of Randomized Crossover and Long-Term Extension Trials
title_full_unstemmed Efficacy and Long-Term Safety of Ibuprofen Gargle for Oral Lichen Planus: A Study Protocol of Randomized Crossover and Long-Term Extension Trials
title_short Efficacy and Long-Term Safety of Ibuprofen Gargle for Oral Lichen Planus: A Study Protocol of Randomized Crossover and Long-Term Extension Trials
title_sort efficacy and long-term safety of ibuprofen gargle for oral lichen planus: a study protocol of randomized crossover and long-term extension trials
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844393/
https://www.ncbi.nlm.nih.gov/pubmed/36648956
http://dx.doi.org/10.3390/mps6010007
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