Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial
Identifieur interne : 000208 ( Main/Exploration ); précédent : 000207; suivant : 000209Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial
Auteurs : Raphael F. De Souza ; Muhammad Faheem Khiyani ; Carolina A. L. Chaves ; Jocelyne Feine ; Jean Barbeau ; Ram N Fuentes [Chili] ; Eduardo Borie [Chili] ; Luciana C. Crizostomo ; Claudia H. Silva-Lovato ; Pierre Rompre ; Elham EmamiSource :
- Trials [ 1745-6215 ] ; 2017.
Abstract
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
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
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.
ClinicalTrials.gov,
The online version of this article (doi:10.1186/s13063-017-1947-y) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/s13063-017-1947-y
PubMed: 28476133
PubMed Central: 5420092
Affiliations:
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Crizostomo</name><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1937 0722</institution-id><institution-id institution-id-type="GRID">grid.11899.38</institution-id><institution>Department of Dental Materials and Prosthetics, School of Dentistry of Ribeirão Preto,</institution><institution>University of São Paulo,</institution></institution-wrap>Ribeirão Preto, SP Brazil</nlm:aff><wicri:noCountry code="subfield">SP Brazil</wicri:noCountry></affiliation></author><author><name sortKey="Silva Lovato, Claudia H" sort="Silva Lovato, Claudia H" uniqKey="Silva Lovato C" first="Claudia H." last="Silva-Lovato">Claudia H. Silva-Lovato</name><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1937 0722</institution-id><institution-id institution-id-type="GRID">grid.11899.38</institution-id><institution>Department of Dental Materials and Prosthetics, School of Dentistry of Ribeirão Preto,</institution><institution>University of São Paulo,</institution></institution-wrap>Ribeirão Preto, SP Brazil</nlm:aff><wicri:noCountry code="subfield">SP Brazil</wicri:noCountry></affiliation></author><author><name sortKey="Rompre, Pierre" sort="Rompre, Pierre" uniqKey="Rompre P" first="Pierre" last="Rompre">Pierre Rompre</name><affiliation><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2292 3357</institution-id><institution-id institution-id-type="GRID">grid.14848.31</institution-id><institution></institution><institution>Faculty of Dental Medicine, Université de Montréal,</institution></institution-wrap>Montreal, QC Canada</nlm:aff><wicri:noCountry code="subfield">QC Canada</wicri:noCountry></affiliation></author><author><name sortKey="Emami, Elham" sort="Emami, Elham" uniqKey="Emami E" first="Elham" last="Emami">Elham Emami</name><affiliation><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2292 3357</institution-id><institution-id institution-id-type="GRID">grid.14848.31</institution-id><institution></institution><institution>Faculty of Dental Medicine, Université de Montréal,</institution></institution-wrap>Montreal, QC Canada</nlm:aff><wicri:noCountry code="subfield">QC Canada</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff5"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2292 3357</institution-id><institution-id institution-id-type="GRID">grid.14848.31</institution-id><institution>School of Public Health, Public Health Institute,</institution><institution>University of Montréal’s Hospitals Research Center, Université de Montréal,</institution></institution-wrap>C.P. 6128, succursale centre-ville, Montréal, QC H3C 3J7 Canada</nlm:aff><wicri:noCountry code="subfield">QC H3C 3J7 Canada</wicri:noCountry></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>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 <italic>Candida</italic> 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 <italic>Candida</italic> 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.</p></sec><sec><title>Methods/design</title><p>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 <italic>Candida</italic> 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.</p></sec><sec><title>Discussion</title><p>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.</p></sec><sec><title>Trial registration</title><p>ClinicalTrials.gov, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02686632">NCT02686632</ext-link>. Registered on 15 February 2016.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/s13063-017-1947-y) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Kulak Ozkan, Y" uniqKey="Kulak Ozkan Y">Y Kulak-Ozkan</name></author><author><name sortKey="Kazazoglu, E" uniqKey="Kazazoglu E">E Kazazoglu</name></author><author><name sortKey="Arikan, A" uniqKey="Arikan A">A Arikan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="D Enfert, C" uniqKey="D Enfert C">C d'Enfert</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Glass, Rt" uniqKey="Glass R">RT Glass</name></author><author><name sortKey="Conrad, Rs" uniqKey="Conrad R">RS Conrad</name></author><author><name sortKey="Bullard, Jw" uniqKey="Bullard J">JW 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L." last="Chaves">Carolina A. L. Chaves</name><name sortKey="Crizostomo, Luciana C" sort="Crizostomo, Luciana C" uniqKey="Crizostomo L" first="Luciana C." last="Crizostomo">Luciana C. Crizostomo</name><name sortKey="De Souza, Raphael F" sort="De Souza, Raphael F" uniqKey="De Souza R" first="Raphael F." last="De Souza">Raphael F. De Souza</name><name sortKey="Emami, Elham" sort="Emami, Elham" uniqKey="Emami E" first="Elham" last="Emami">Elham Emami</name><name sortKey="Feine, Jocelyne" sort="Feine, Jocelyne" uniqKey="Feine J" first="Jocelyne" last="Feine">Jocelyne Feine</name><name sortKey="Khiyani, Muhammad Faheem" sort="Khiyani, Muhammad Faheem" uniqKey="Khiyani M" first="Muhammad Faheem" last="Khiyani">Muhammad Faheem Khiyani</name><name sortKey="Rompre, Pierre" sort="Rompre, Pierre" uniqKey="Rompre P" first="Pierre" last="Rompre">Pierre Rompre</name><name sortKey="Silva Lovato, Claudia H" sort="Silva Lovato, Claudia H" uniqKey="Silva Lovato C" first="Claudia H." last="Silva-Lovato">Claudia H. Silva-Lovato</name></noCountry><country name="Chili"><noRegion><name sortKey="Fuentes, Ram N" sort="Fuentes, Ram N" uniqKey="Fuentes R" first="Ram N" last="Fuentes">Ram N Fuentes</name></noRegion><name sortKey="Borie, Eduardo" sort="Borie, Eduardo" uniqKey="Borie E" first="Eduardo" last="Borie">Eduardo Borie</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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