Evaluation of cinnamaldehyde mucoadhesive patches on minor recurrent aphthous stomatitis: a randomized, double-blind, placebo-controlled clinical trial

Abstract Background & objective The use of herbal medicines to treat common oral diseases increases rapidly. Recurrent aphthous stomatitis is one of the most common oral mucosal diseases, which has an unclear etiology and could lead to severe pain and dysfunction. Cinnamaldehyde is a major compo...

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Main Authors: Tahere Molania, Ali Malekzadeh Shafaroudi, Majid Saeedi, Mahmood Moosazadeh, Faeze Valipour, Seyyed Sohrab Rostamkalaei, Negareh Salehabadi, Maede Salehi
Format: Article
Language:English
Published: BMC 2022-06-01
Series:BMC Oral Health
Subjects:
Online Access:https://doi.org/10.1186/s12903-022-02248-5
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author Tahere Molania
Ali Malekzadeh Shafaroudi
Majid Saeedi
Mahmood Moosazadeh
Faeze Valipour
Seyyed Sohrab Rostamkalaei
Negareh Salehabadi
Maede Salehi
author_facet Tahere Molania
Ali Malekzadeh Shafaroudi
Majid Saeedi
Mahmood Moosazadeh
Faeze Valipour
Seyyed Sohrab Rostamkalaei
Negareh Salehabadi
Maede Salehi
author_sort Tahere Molania
collection DOAJ
description Abstract Background & objective The use of herbal medicines to treat common oral diseases increases rapidly. Recurrent aphthous stomatitis is one of the most common oral mucosal diseases, which has an unclear etiology and could lead to severe pain and dysfunction. Cinnamaldehyde is a major component of cinnamon bark oil. Biological properties of cinnamaldehyde, such as antioxidant, antitumor, antifungal, cytotoxic, and anti-mutational characteristics, have been identified. Considering the prevalence of recurrent aphthous stomatitis and the importance of using herbal resources for treatment, the present study aimed to evaluate the effect of mucosal adhesive patches containing Cinnamaldehyde on minor recurrent aphthous stomatitis lesions. Material & methods In this randomized, double-blind clinical trial, patients were divided into two groups. The intervention group received three daily mucosal adhesive patches to be used in the morning, afternoon, and night. The control group also did the same with a placebo. To evaluate the healing and determine the diameter of the lesions, patients were clinically examined on days zero, 3, 5, and 7. The VAS scale evaluated pain at baseline and after each meal for seven days. The Fisher's exact test, t-test, Shapiro Wilk test, Friedman test, and the Mann–Whitney test were used to analyze the data using the SPSS 20 software. Results There was no statistically significant difference in the mean diameter of the inflammatory lesion and pain intensity in the two groups in the baseline (p > 0.05). However, the ulcer size was significantly reduced in the cinnamaldehyde group on the third, fifth, and seventh days of the study. Except for baseline, the mean pain intensity significantly decreased in the cinnamaldehyde group compared to the placebo group (p < 0.05). Conclusion Cinnamaldehyde mucoadhesive patches effectively reduced and improved aphthous lesions and pain intensity in patients and can be considered a treatment for RAS. Registration number: IRCT20180312039060N2—First registration date: 20/07/2018. The present study was registered as a retrospective study.
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spelling doaj.art-10ad5606732a4aba9c7db6f6a32b55ff2022-12-22T02:34:11ZengBMCBMC Oral Health1472-68312022-06-012211710.1186/s12903-022-02248-5Evaluation of cinnamaldehyde mucoadhesive patches on minor recurrent aphthous stomatitis: a randomized, double-blind, placebo-controlled clinical trialTahere Molania0Ali Malekzadeh Shafaroudi1Majid Saeedi2Mahmood Moosazadeh3Faeze Valipour4Seyyed Sohrab Rostamkalaei5Negareh Salehabadi6Maede Salehi7Department of Oral Medicine, Faculty of Dentistry, Mazandaran University of Medical SciencesStudent Research Committee, Faculty of Dentistry, Mazandaran University of Medical SciencesDepartment of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical SciencesGastroinstitional Cancer Research Center, Non-Communicable Diseases Institute, Mazandaran University of Medical SciencesMazandaran University of Medical SciencesDepartment of Pharmaceutics, Faculty of Pharmacy, Ayatollah Amoli Branch, Islamic Azad UniversityStudent Research Committee, Faculty of Dentistry, Mazandaran University of Medical SciencesDepartment of Oral Medicine, Faculty of Dentistry, Mazandaran University of Medical SciencesAbstract Background & objective The use of herbal medicines to treat common oral diseases increases rapidly. Recurrent aphthous stomatitis is one of the most common oral mucosal diseases, which has an unclear etiology and could lead to severe pain and dysfunction. Cinnamaldehyde is a major component of cinnamon bark oil. Biological properties of cinnamaldehyde, such as antioxidant, antitumor, antifungal, cytotoxic, and anti-mutational characteristics, have been identified. Considering the prevalence of recurrent aphthous stomatitis and the importance of using herbal resources for treatment, the present study aimed to evaluate the effect of mucosal adhesive patches containing Cinnamaldehyde on minor recurrent aphthous stomatitis lesions. Material & methods In this randomized, double-blind clinical trial, patients were divided into two groups. The intervention group received three daily mucosal adhesive patches to be used in the morning, afternoon, and night. The control group also did the same with a placebo. To evaluate the healing and determine the diameter of the lesions, patients were clinically examined on days zero, 3, 5, and 7. The VAS scale evaluated pain at baseline and after each meal for seven days. The Fisher's exact test, t-test, Shapiro Wilk test, Friedman test, and the Mann–Whitney test were used to analyze the data using the SPSS 20 software. Results There was no statistically significant difference in the mean diameter of the inflammatory lesion and pain intensity in the two groups in the baseline (p > 0.05). However, the ulcer size was significantly reduced in the cinnamaldehyde group on the third, fifth, and seventh days of the study. Except for baseline, the mean pain intensity significantly decreased in the cinnamaldehyde group compared to the placebo group (p < 0.05). Conclusion Cinnamaldehyde mucoadhesive patches effectively reduced and improved aphthous lesions and pain intensity in patients and can be considered a treatment for RAS. Registration number: IRCT20180312039060N2—First registration date: 20/07/2018. The present study was registered as a retrospective study.https://doi.org/10.1186/s12903-022-02248-5Recurrent aphthous ulcerCinnamaldehydeTreatment
spellingShingle Tahere Molania
Ali Malekzadeh Shafaroudi
Majid Saeedi
Mahmood Moosazadeh
Faeze Valipour
Seyyed Sohrab Rostamkalaei
Negareh Salehabadi
Maede Salehi
Evaluation of cinnamaldehyde mucoadhesive patches on minor recurrent aphthous stomatitis: a randomized, double-blind, placebo-controlled clinical trial
BMC Oral Health
Recurrent aphthous ulcer
Cinnamaldehyde
Treatment
title Evaluation of cinnamaldehyde mucoadhesive patches on minor recurrent aphthous stomatitis: a randomized, double-blind, placebo-controlled clinical trial
title_full Evaluation of cinnamaldehyde mucoadhesive patches on minor recurrent aphthous stomatitis: a randomized, double-blind, placebo-controlled clinical trial
title_fullStr Evaluation of cinnamaldehyde mucoadhesive patches on minor recurrent aphthous stomatitis: a randomized, double-blind, placebo-controlled clinical trial
title_full_unstemmed Evaluation of cinnamaldehyde mucoadhesive patches on minor recurrent aphthous stomatitis: a randomized, double-blind, placebo-controlled clinical trial
title_short Evaluation of cinnamaldehyde mucoadhesive patches on minor recurrent aphthous stomatitis: a randomized, double-blind, placebo-controlled clinical trial
title_sort evaluation of cinnamaldehyde mucoadhesive patches on minor recurrent aphthous stomatitis a randomized double blind placebo controlled clinical trial
topic Recurrent aphthous ulcer
Cinnamaldehyde
Treatment
url https://doi.org/10.1186/s12903-022-02248-5
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