Skip to main content
Top
Published in: Trials 1/2019

Open Access 01-12-2019 | Denture | Study protocol

Hygiene protocols for the treatment of denture-related stomatitis: local and systemic parameters analysis - a randomized, double-blind trial protocol

Authors: Adriana B. Ribeiro, Camila B. de Araújo, Luiz Eduardo V. Silva, Rubens Fazan-Junior, Helio C. Salgado, Aline B. Ribeiro, Caroline V. Fortes, Frank L. Bueno, Viviane C. de Oliveira, Helena de F. O. Paranhos, Evandro Watanabe, Cláudia H. da Silva-Lovato

Published in: Trials | Issue 1/2019

Login to get access

Abstract

Background

Denture-related stomatitis (DS) is chronic multifactorial inflammation, strongly related to the presence of the biofilm that is the complex structure formed by microorganisms held together by a mucus-like matrix of carbohydrate that adheres to different surfaces, including the denture surface. DS has recently been correlated with deleterious cardiovascular alterations. The potential effect of hygiene protocols in the control of DS and randomized clinical trials that address this oral condition with cardiovascular complications are important in clinical decision-making.

Material/design

A clinical trial, randomized, double-blind, and with parallel groups, will be conducted in Brazil The sample will consist of 100 patients without teeth in both arches, users of at least maxillary complete dentures, and diagnosed with DS, who will be allocated to groups (n = 25 per group) according to the different hygiene protocols: (1) brushing of the palate and immersion of the prosthesis in 0.25% sodium hypochlorite solution (positive control); (2) brushing of the palate and immersion of the prosthesis in 0.15% triclosan solution; (3) brushing of the palate and immersion of the prosthesis in lactose monohydrate; or (4) brushing the palate with citric acid and immersing the prosthesis in lactose monohydrate. The response variables will be heart rate variability and alteration of blood pressure (systemic level), remission of DS, removal of biofilm, reduction of microbial load (colony-forming units (CFU)), mouth and prosthesis odor level, expression of MUC1, proinflammatory cytokines, C-reactive protein (CRP), viscosity, pH and salivary flow (locally); patient-centred qualitative analysis will also be undertaken. Measurements will be performed at baseline and 10 days after the interventions. The results obtained will be statistically analyzed as pertinent, with a level of significance of 0.05.

Discussion

This study will provide a guideline for clinical practice regarding the use of hygiene protocols in the treatment of oral diseases (DS) mediated by biofilm. Also, it may provide evidence of correlation of oral manifestation with cardiac risk.

Trial registration

Brazilian Registry of Clinical Trials, RBR-4hhwjb. Registered on 9 November 2018.
Appendix
Available only for authorised users
Literature
2.
go back to reference 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(3):300–4.CrossRef 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(3):300–4.CrossRef
3.
11.
14.
go back to reference Salerno C, Pascale M, Contaldo M, Esposito V, Busciolano M, Milillo L, et al. Candida-associated denture stomatitis. Med Oral Patol Oral Cir Bucal. 2011;16:e139–43.CrossRef Salerno C, Pascale M, Contaldo M, Esposito V, Busciolano M, Milillo L, et al. Candida-associated denture stomatitis. Med Oral Patol Oral Cir Bucal. 2011;16:e139–43.CrossRef
17.
go back to reference Osmenda G, Maciąg J, Wilk G, Maciąg A, Nowakowski D, Loster J, Dembowska E, Robertson D, Guzik T, Cześnikiewicz-Guzik M. Treatment of denture-related stomatitis improves endothelial function assessed by flow-mediated vascular dilation. Arch Med Sci. 2017. https://doi.org/10.5114/aoms.2017.64715. Osmenda G, Maciąg J, Wilk G, Maciąg A, Nowakowski D, Loster J, Dembowska E, Robertson D, Guzik T, Cześnikiewicz-Guzik M. Treatment of denture-related stomatitis improves endothelial function assessed by flow-mediated vascular dilation. Arch Med Sci. 2017. https://​doi.​org/​10.​5114/​aoms.​2017.​64715.
18.
go back to reference Maciag J, Osmenda G, Nowakowski D, Wilk G, Maciag A, Mikolajczyk T, Nosalski R, Sagan A, Filip M, Dróżdż M, Loster J, Guzik TJ, Cześnikiewicz-Guzik M. Denture-related stomatitis is associated with endothelial dysfunction. Biomed Res Int. 2014. https://doi.org/10.1155/2014/474016. Maciag J, Osmenda G, Nowakowski D, Wilk G, Maciag A, Mikolajczyk T, Nosalski R, Sagan A, Filip M, Dróżdż M, Loster J, Guzik TJ, Cześnikiewicz-Guzik M. Denture-related stomatitis is associated with endothelial dysfunction. Biomed Res Int. 2014. https://​doi.​org/​10.​1155/​2014/​474016.
26.
27.
go back to reference Gidron Y, Deschepper R, De Couck M, Thayer JF, Velkeniers B. The vagus nerve can predict and possibly modulate non-communicable chronic diseases: introducing a neuroimmunological paradigm to public health. J Clin Med. 2018. https://doi.org/10.3390/jcm7100371. Gidron Y, Deschepper R, De Couck M, Thayer JF, Velkeniers B. The vagus nerve can predict and possibly modulate non-communicable chronic diseases: introducing a neuroimmunological paradigm to public health. J Clin Med. 2018. https://​doi.​org/​10.​3390/​jcm7100371.
28.
go back to reference Anastassiadou V, Naka O, Heath MR, Kapari D. Validation of índices for funtional assessment of dentures. Gerodontology. 2002;19:46–52.CrossRef Anastassiadou V, Naka O, Heath MR, Kapari D. Validation of índices for funtional assessment of dentures. Gerodontology. 2002;19:46–52.CrossRef
29.
go back to reference de Souza RF, Khiyani MF, Chaves CAL, Feine J, Barbeau J, Fuentes R, Borie E, Crizostomo LC, Silva-Lovato CH, Rompre P, Emami E. Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial. Trials. 2017. https://doi.org/10.1186/s13063-017-1947-y. de Souza RF, Khiyani MF, Chaves CAL, Feine J, Barbeau J, Fuentes R, Borie E, Crizostomo LC, Silva-Lovato CH, Rompre P, Emami E. Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial. Trials. 2017. https://​doi.​org/​10.​1186/​s13063-017-1947-y.
30.
go back to reference Pedrazzi V, Sato S, de Mattos Mda G, Lara EH, Panzeri H. Tongue-cleaning methods: a comparative clinical trial employing a toothbrush and a tongue scraper. J Periodontol. 2004;75(7):1009–12.CrossRef Pedrazzi V, Sato S, de Mattos Mda G, Lara EH, Panzeri H. Tongue-cleaning methods: a comparative clinical trial employing a toothbrush and a tongue scraper. J Periodontol. 2004;75(7):1009–12.CrossRef
32.
go back to reference Ramírez-Amador V, Zambrano JG, Anaya-Saavedra G, Zentella-Dehesa A, Irigoyen-Camacho E, Meráz-Cruz N, Ponce de León-Rosales S. TNF as marker of oral candidiasis, HSV infection, and mucositis onset during chemotherapy in leukemia patients. Oral Dis. 2017;23(7):941–8. https://doi.org/10.1111/odi.12677.CrossRefPubMed Ramírez-Amador V, Zambrano JG, Anaya-Saavedra G, Zentella-Dehesa A, Irigoyen-Camacho E, Meráz-Cruz N, Ponce de León-Rosales S. TNF as marker of oral candidiasis, HSV infection, and mucositis onset during chemotherapy in leukemia patients. Oral Dis. 2017;23(7):941–8. https://​doi.​org/​10.​1111/​odi.​12677.CrossRefPubMed
33.
go back to reference Justino CI, Duarte K, Lucas S, Chaves P, Bettencourt P, Freitas AC, Pereira R, Cardoso S, Duarte AC, Rocha-Santos TA. Assessment of cardiovascular disease risk using immunosensors for determination of C-reactive protein levels in serum and saliva: a pilot study. Bioanalysis. 2014. https://doi.org/10.4155/bio.14.12. Justino CI, Duarte K, Lucas S, Chaves P, Bettencourt P, Freitas AC, Pereira R, Cardoso S, Duarte AC, Rocha-Santos TA. Assessment of cardiovascular disease risk using immunosensors for determination of C-reactive protein levels in serum and saliva: a pilot study. Bioanalysis. 2014. https://​doi.​org/​10.​4155/​bio.​14.​12.
34.
go back to reference Souza RF, Patrocínio L, Pero AC, Marra J, Compagnoni MA. Reliability and validation of a Brazilian version of the Oral Health Impact Profile for assessing edentulous subjects. J Oral Rehabil. 2007;34(11):821–6.CrossRef Souza RF, Patrocínio L, Pero AC, Marra J, Compagnoni MA. Reliability and validation of a Brazilian version of the Oral Health Impact Profile for assessing edentulous subjects. J Oral Rehabil. 2007;34(11):821–6.CrossRef
Metadata
Title
Hygiene protocols for the treatment of denture-related stomatitis: local and systemic parameters analysis - a randomized, double-blind trial protocol
Authors
Adriana B. Ribeiro
Camila B. de Araújo
Luiz Eduardo V. Silva
Rubens Fazan-Junior
Helio C. Salgado
Aline B. Ribeiro
Caroline V. Fortes
Frank L. Bueno
Viviane C. de Oliveira
Helena de F. O. Paranhos
Evandro Watanabe
Cláudia H. da Silva-Lovato
Publication date
01-12-2019
Publisher
BioMed Central
Keyword
Denture
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3854-x

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue