Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial
Abstract Background Denture-related erythematous stomatitis (DES) is a chronic biofilm-mediated disease, affecting one in every three complete denture wearers. Antifungals are the treatment most commonly prescribed by oral health professionals, based on the belief that colonization by Candida spp. i...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2017-05-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-1947-y |
| _version_ | 1818540355163783168 |
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| author | Raphael F. de Souza Muhammad Faheem Khiyani Carolina A. L. Chaves Jocelyne Feine Jean Barbeau Ramón Fuentes Eduardo Borie Luciana C. Crizostomo Claudia H. Silva-Lovato Pierre Rompre Elham Emami |
| author_facet | Raphael F. de Souza Muhammad Faheem Khiyani Carolina A. L. Chaves Jocelyne Feine Jean Barbeau Ramón Fuentes Eduardo Borie Luciana C. Crizostomo Claudia H. Silva-Lovato Pierre Rompre Elham Emami |
| author_sort | Raphael F. de Souza |
| collection | DOAJ |
| description | Abstract Background Denture-related erythematous stomatitis (DES) is a chronic biofilm-mediated disease, affecting one in every three complete denture wearers. Antifungals are the treatment most commonly prescribed by oral health professionals, based on the belief that colonization by Candida spp. is the main cause of DES. However, high recurrence rates and adverse effects are commonly observed, prompting the need for practice guidelines regarding treatment. Results from our pilot study demonstrate that palatal brushing can reduce the palatal inflammation and potentially associated Candida carriage without any need for antifungal therapy. The objective of this study is to validate these pilot results by means of a randomized controlled trial (RCT) and provide a practice guideline for clinicians. Methods/design A pragmatic, two-parallel-arm, multicenter RCT will be conducted in Canada, Brazil, and Chile. Fifty-two adult complete denture wearers presenting with moderate to severe DES will be allocated randomly to two groups: the Intervention arm will consist of palatal brushing and standard oral and denture hygiene measures, while the Control arm will include only standard oral and denture hygiene measures. The study outcome will be the oral Candida carriage. Participants will be assessed at baseline, and at 3 and 6 months post intervention. Descriptive, bivariate, and mixed models with repeated measures will be performed following the intention-to-treat principle. Discussion This pragmatic RCT will serve to provide a clinical practice guideline regarding the use of preventive measures in the treatment of biofilm-mediated oral diseases. Moreover, it will have a great impact on reducing the harm of antifungal overtreatment on patients suffering from DES. Trial registration ClinicalTrials.gov, NCT02686632 . Registered on 15 February 2016. |
| first_indexed | 2024-12-11T21:54:15Z |
| format | Article |
| id | doaj.art-cf498bb7071741ee95ae9652da91188a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-11T21:54:15Z |
| publishDate | 2017-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-cf498bb7071741ee95ae9652da91188a2022-12-22T00:49:22ZengBMCTrials1745-62152017-05-011811810.1186/s13063-017-1947-yImproving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trialRaphael F. de Souza0Muhammad Faheem Khiyani1Carolina A. L. Chaves2Jocelyne Feine3Jean Barbeau4Ramón Fuentes5Eduardo Borie6Luciana C. Crizostomo7Claudia H. Silva-Lovato8Pierre Rompre9Elham Emami10Division of Oral Health and Society, Faculty of Dentistry, McGill UniversityFaculty of Dental Medicine, Université de MontréalFaculty of Dental Medicine, Université de MontréalDivision of Oral Health and Society, Faculty of Dentistry, McGill UniversityFaculty of Dental Medicine, Université de MontréalResearch Centre in Dental Sciences (CICO), Faculty of Dentistry, Universidad de la FronteraResearch Centre in Dental Sciences (CICO), Faculty of Dentistry, Universidad de la FronteraDepartment of Dental Materials and Prosthetics, School of Dentistry of Ribeirão Preto, University of São PauloDepartment of Dental Materials and Prosthetics, School of Dentistry of Ribeirão Preto, University of São PauloFaculty of Dental Medicine, Université de MontréalFaculty of Dental Medicine, Université de MontréalAbstract Background Denture-related erythematous stomatitis (DES) is a chronic biofilm-mediated disease, affecting one in every three complete denture wearers. Antifungals are the treatment most commonly prescribed by oral health professionals, based on the belief that colonization by Candida spp. is the main cause of DES. However, high recurrence rates and adverse effects are commonly observed, prompting the need for practice guidelines regarding treatment. Results from our pilot study demonstrate that palatal brushing can reduce the palatal inflammation and potentially associated Candida carriage without any need for antifungal therapy. The objective of this study is to validate these pilot results by means of a randomized controlled trial (RCT) and provide a practice guideline for clinicians. Methods/design A pragmatic, two-parallel-arm, multicenter RCT will be conducted in Canada, Brazil, and Chile. Fifty-two adult complete denture wearers presenting with moderate to severe DES will be allocated randomly to two groups: the Intervention arm will consist of palatal brushing and standard oral and denture hygiene measures, while the Control arm will include only standard oral and denture hygiene measures. The study outcome will be the oral Candida carriage. Participants will be assessed at baseline, and at 3 and 6 months post intervention. Descriptive, bivariate, and mixed models with repeated measures will be performed following the intention-to-treat principle. Discussion This pragmatic RCT will serve to provide a clinical practice guideline regarding the use of preventive measures in the treatment of biofilm-mediated oral diseases. Moreover, it will have a great impact on reducing the harm of antifungal overtreatment on patients suffering from DES. Trial registration ClinicalTrials.gov, NCT02686632 . Registered on 15 February 2016.http://link.springer.com/article/10.1186/s13063-017-1947-yDenture stomatitisComplete dentureCandidaOral candidosisPragmatic trials |
| spellingShingle | Raphael F. de Souza Muhammad Faheem Khiyani Carolina A. L. Chaves Jocelyne Feine Jean Barbeau Ramón Fuentes Eduardo Borie Luciana C. Crizostomo Claudia H. Silva-Lovato Pierre Rompre Elham Emami Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial Trials Denture stomatitis Complete denture Candida Oral candidosis Pragmatic trials |
| title | Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial |
| title_full | Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial |
| title_fullStr | Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial |
| title_full_unstemmed | Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial |
| title_short | Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial |
| title_sort | improving practice guidelines for the treatment of denture related erythematous stomatitis a study protocol for a randomized controlled trial |
| topic | Denture stomatitis Complete denture Candida Oral candidosis Pragmatic trials |
| url | http://link.springer.com/article/10.1186/s13063-017-1947-y |
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