Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial

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, 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

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.

Keywords: Candida; Complete denture; Denture stomatitis; Oral candidosis; Pragmatic trials.

Figures

Fig. 1
Fig. 1
CONSORT study flowchart. Numbers of withdrawn and lost participants will be reported for each follow-up
Fig. 2
Fig. 2
Study schedule: enrolment, allocation, interventions, baseline, and post-intervention assessments

References

    1. Kulak-Ozkan Y, Kazazoglu E, Arikan A. Oral hygiene habits, denture cleanliness, presence of yeasts and stomatitis in elderly people. J Oral Rehabil. 2002;29:300–4. doi: 10.1046/j.1365-2842.2002.00816.x.
    1. d'Enfert C. Biofilms and their role in the resistance of pathogenic Candida to antifungal agents. Curr Drug Targets. 2006;7:465–70. doi: 10.2174/138945006776359458.
    1. Glass RT, Conrad RS, Bullard JW, Goodson LB, Mehta N, Lech SJ, Loewy ZG. Evaluation of microbial flora found in previously worn prostheses from the Northeast and Southwest regions of the United States. J Prosthet Dent. 2010;103:384–9. doi: 10.1016/S0022-3913(10)60083-2.
    1. dos Santos CM, Hilgert JB, Padilha DM, Hugo FN. Denture stomatitis and its risk indicators in south Brazilian older adults. Gerodontology. 2010;27:134–40. doi: 10.1111/j.1741-2358.2009.00295.x.
    1. Glass RT, Conrad RS, Bullard JW, Goodson LB, Mehta N, Lech SJ, Loewy ZG. Evaluation of cleansing methods for previously worn prostheses. Compend Contin Educ Dent. 2011;32:68–73.
    1. Sumi Y, Miura H, Sunakawa M, Michiwaki Y, Sakagami N. Colonization of denture plaque by respiratory pathogens in dependent elderly. Gerodontology. 2002;19:25–9. doi: 10.1111/j.1741-2358.2002.00025.x.
    1. Sumi Y, Kagami H, Ohtsuka Y, Kakinoki Y, Haruguchi Y, Miyamoto H. High correlation between the bacterial species in denture plaque and pharyngeal microflora. Gerodontology. 2003;20:84–7. doi: 10.1111/j.1741-2358.2003.00084.x.
    1. Kim J, Amar S. Periodontal disease and systemic conditions: a bidirectional relationship. Odontology. 2006;94:10–21. doi: 10.1007/s10266-006-0060-6.
    1. Zarco MF, Vess TJ, Ginsburg GS. The oral microbiome in health and disease and the potential impact on personalized dental medicine. Oral Dis. 2012;18:109–20. doi: 10.1111/j.1601-0825.2011.01851.x.
    1. Sacristan JA. Patient-centered medicine and patient-oriented research: improving health outcomes for individual patients. BMC Med Inform Decis Mak. 2013;13:6. doi: 10.1186/1472-6947-13-6.
    1. Vineis P. Evidence-based medicine and ethics: a practical approach. J Med Ethics. 2004;30:126–30. doi: 10.1136/jme.2003.007211.
    1. Carrasco-Labra A, Brignardello-Petersen R, Glick M, Guyatt GH, Neumann I, Azarpazhooh A. A practical approach to evidence-based dentistry: VII: how to use patient management recommendations from clinical practice guidelines. J Am Dent Assoc. 2015;146:327–36.e1. doi: 10.1016/j.adaj.2015.03.015.
    1. Petersen PE. The World Oral Health Report 2003: continuous improvement of oral health in the 21st century—the approach of the WHO Global Oral Health Programme. Community Dent Oral Epidemiol. 2003;31(Suppl 1):3–23. doi: 10.1046/j..2003.com122.x.
    1. Robbins SL, Kumar V, Cotran RS. Robbins and Cotran pathologic basis of disease. 8. Philadelphia: Saunders/Elsevier; 2010.
    1. Rubin R, Strayer DS, Rubin E. Rubin’s pathology: clinicopathologic foundations of medicine. 6. Philadelphia: Wolters Kluwer Health/Lippincott Williams & Wilkins; 2012.
    1. Wilson J. The aetiology, diagnosis and management of denture stomatitis. Br Dent J. 1998;185:380–4. doi: 10.1038/sj.bdj.4809821.
    1. Budtz-Jorgensen E, Bertram U. Denture stomatitis. I. The etiology in relation to trauma and infection. Acta Odontol Scand. 1970;28:71–92. doi: 10.3109/00016357009033133.
    1. Gendreau L, Loewy ZG. Epidemiology and etiology of denture stomatitis. J Prosthodont. 2011;20:251–60. doi: 10.1111/j.1532-849X.2011.00698.x.
    1. Jainkittivong A, Aneksuk V, Langlais RP. Oral mucosal lesions in denture wearers. Gerodontology. 2010;27:26–32. doi: 10.1111/j.1741-2358.2009.00289.x.
    1. Petersen PE, Yamamoto T. Improving the oral health of older people: the approach of the WHO Global Oral Health Programme. Community Dent Oral Epidemiol. 2005;33:81–92. doi: 10.1111/j.1600-0528.2004.00219.x.
    1. Shulman JD, Rivera-Hidalgo F, Beach MM. Risk factors associated with denture stomatitis in the United States. J Oral Pathol Med. 2005;34:340–6. doi: 10.1111/j.1600-0714.2005.00287.x.
    1. Slade GD, Akinkugbe AA, Sanders AE. Projections of U.S. Edentulism prevalence following 5 decades of decline. J Dent Res. 2014;93:959–65. doi: 10.1177/0022034514546165.
    1. Girard B, Jr, Landry RG, Giasson L. Denture stomatitis: etiology and clinical considerations. J Can Dent Assoc. 1996;62:808–12.
    1. Moskona D, Kaplan I. Oral lesions in elderly denture wearers. Clin Prev Dent. 1992;14:11–4.
    1. Gusmao JM, Santos SSFd, Neisser MP, Jorge AO, Faria MI. Correlation between factors associated with the removable partial dentures use and Candida spp in saliva. Gerodontology. 2011;28:283–8. doi: 10.1111/j.1741-2358.2010.00390.x.
    1. Shimizu K, Shimizu F, Kamiyama K. Microbiological studies on denture-induced stomatitis in children. Pediatr Dent. 1987;9:304–7.
    1. Mattos BS, Sousa AA, Magalhaes MH, Andre M, Brito EDR. Candida albicans in patients with oronasal communication and obturator prostheses. Braz Dent J. 2009;20:336–40. doi: 10.1590/S0103-64402009000400013.
    1. Douglass CW, Jimenez MC. Our current geriatric population: demographic and oral health care utilization. Dent Clin North Am. 2014;58:717–28. doi: 10.1016/j.cden.2014.06.001.
    1. Epstein JB, Chow AW. Oral complications associated with immunosuppression and cancer therapies. Infect Dis Clin North Am. 1999;13:901–23. doi: 10.1016/S0891-5520(05)70115-X.
    1. Pace CC, McCullough GH. The association between oral microorgansims and aspiration pneumonia in the institutionalized elderly: review and recommendations. Dysphagia. 2010;25:307–22. doi: 10.1007/s00455-010-9298-9.
    1. de Oliveira CE, Gasparoto TH, Dionisio TJ, Porto VC, Vieira NA, Santos CF, Lara VS. Candida albicans and denture stomatitis: evaluation of its presence in the lesion, prosthesis, and blood. Int J Prosthodont. 2010;23:158–9.
    1. Budtz-Jorgensen E, Carlino P. A miconazole lacquer in the treatment of Candida-associated denture stomatitis. Mycoses. 1994;37:131–5. doi: 10.1111/j.1439-0507.1994.tb00789.x.
    1. Khozeimeh F, Shahtalebi MA, Noori M, Savabi O. Comparative evaluation of ketoconazole tablet and topical ketoconazole 2% in orabase in treatment of Candida-infected denture stomatitis. J Contemp Dent Pract. 2010;11:17–24.
    1. Jeganathan S, Lin CC. Denture stomatitis—a review of the aetiology, diagnosis and management. Aust Dent J. 1992;37:107–14. doi: 10.1111/j.1834-7819.1992.tb03046.x.
    1. Rautemaa R, Ramage G. Oral candidosis—clinical challenges of a biofilm disease. Crit Rev Microbiol. 2011;37:328–36. doi: 10.3109/1040841X.2011.585606.
    1. Cross LJ, Williams DW, Sweeney CP, Jackson MS, Lewis MAO, Bagg J. Evaluation of the recurrence of denture stomatitis and Candida colonization in a small group of patients who received itraconazole. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004;97:351–8. doi: 10.1016/j.tripleo.2003.10.006.
    1. Bissell V, Felix DH, Wray D. Comparative trial of fluconazole and amphotericin in the treatment of denture stomatitis. Oral Surg Oral Med Oral Pathol. 1993;76:35–9. doi: 10.1016/0030-4220(93)90290-K.
    1. Capistrano HM, de Assis EM, Leal RM, Alvarez-Leite ME, Brener S, Bastos EM. Brazilian green propolis compared to miconazole gel in the treatment of Candida-associated denture stomatitis. Evid Based Complement Alternat Med. 2013;2013:947980. doi: 10.1155/2013/947980.
    1. Emami E, Kabawat M, Rompre PH, Feine JS. Linking evidence to treatment for denture stomatitis: a meta-analysis of randomized controlled trials. J Dent. 2014;42:99–106. doi: 10.1016/j.jdent.2013.11.021.
    1. Emami E, de Grandmont P, Rompre PH, Barbeau J, Pan S, Feine JS. Favoring trauma as an etiological factor in denture stomatitis. J Dent Res. 2008;87:440–4. doi: 10.1177/154405910808700505.
    1. Kabawat M, de Souza RF, Badaro MM, de Koninck L, Barbeau J, Rompre P, Emami E. Phase 1 clinical trial on the effect of palatal brushing on denture stomatitis. Int J Prosthodont. 2014;27:311–9. doi: 10.11607/ijp.3844.
    1. Hilgert JBGJ, de Souza RF, Wendland EMR, D'Avila OP, Hugo FN. Interventions for the management of denture stomatitis: a systematic review and meta-analysis. J Am Geriatr Soc. 2016;64:2539–45. doi: 10.1111/jgs.14399.
    1. Schwartz IS, Young JM, Berrong JM. The effect of Listerine antiseptic on denture microbial flora and denture stomatitis. Int J Prosthodont. 1988;1:153–8.
    1. Emami E, Seguin J, Rompre PH, de Koninck L, de Grandmont P, Barbeau J. The relationship of myceliated colonies of Candida albicans with denture stomatitis: an in vivo/in vitro study. Int J Prosthodont. 2007;20:514–20.
    1. Hoad-Reddick G, Grant AA, Griffiths CS. Investigation into the cleanliness of dentures in an elderly population. J Prosthet Dent. 1990;64:48–52. doi: 10.1016/0022-3913(90)90152-3.
    1. Webb BC, Thomas CJ, Whittle T. A 2-year study of Candida-associated denture stomatitis treatment in aged care subjects. Gerodontology. 2005;22:168–76. doi: 10.1111/j.1741-2358.2005.00065.x.
    1. Al-Fattani MA, Douglas LJ. Biofilm matrix of Candida albicans and Candida tropicalis: chemical composition and role in drug resistance. J Med Microbiol. 2006;55:999–1008. doi: 10.1099/jmm.0.46569-0.
    1. Silva M, Consani R, Sardi J, Mesquita M, Macedo A, Takahashi J. Microwave irradiation as an alternative method for disinfection of denture base acrylic resins. Minerva Stomatol. 2013;62:23–9.
    1. Sussman JB, Hayward RA. An IV for the RCT: using instrumental variables to adjust for treatment contamination in randomised controlled trials. BMJ. 2010;340:c2073. doi: 10.1136/bmj.c2073.

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