Efficacy and safety of a new oral saliva equivalent in the management of xerostomia: a national, multicenter, randomized study

Salom, Michel; Hachulla, É.; Bertolus, Chloé; Simoneau, Guy G.; Mouly, Stéphane

doi:10.1016/j.oooo.2014.12.005

Cited by 19 publications

(14 citation statements)

References 27 publications

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“…Corresponding authors of these two papers were contacted for obtaining full texts but they failed to reply. [2324] After evaluation of full texts, 11 studies were excluded. Reasons for exclusion are mentioned in flow chart.…”

Section: Resultsmentioning

confidence: 99%

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Efficacy of artificial salivary substitutes in treatment of xerostomia: A systematic review

Assery

2019

J Pharm Bioall Sci

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Aim: To provide an update on artificial saliva used to maintain the health of the oral cavity of patients with severe hyposalivation. Materials and Methods: A literature search was conducted in April 2018 in three electronic databases (The Cochrane Central Register of Controlled Trials [CENTRAL], PubMed, and Embase) by combining key words and terms related to the population and intervention of the topic. Results: The databases search resulted in 455 titles and abstracts. Of these, 21 were judged to meet inclusion criteria and full texts were read. Finally, 10 clinical trials were included for qualitative synthesis. Conclusion: Published evidence suggests that all the artificial saliva products tested in included studies reduced symptoms of xerostomia. These products should specifically be selected according to the patients’ concerns and needs. However, the included studies presented a wide range of products and suffered from high risk of bias. Therefore, long-term randomized controlled trials on effects of various products are required.

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Section: Resultsmentioning

confidence: 99%

“…Full texts of two studies were not found after contacting the authors as they did not reply. [2324] Therefore, those studies could not be included in this review, which may cause bias. This review may be subject to publication bias as unpublished literature was not included in the study.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of artificial salivary substitutes in treatment of xerostomia: A systematic review

Assery

2019

J Pharm Bioall Sci

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“…They are the simplest and cheapest therapeutic option in this context. There is some evidence that they reduce symptoms in the context of chronic xerostomia [6]. There are a number of preparations available over the counter in the form of lozenges, sprays, mouth rinses, gels, oils, chewing gums and pastes.…”

Section: Introductionmentioning

confidence: 99%

A randomised controlled pilot trial of two interventions to manage dry mouth in pre-operative elective surgical patients

Morton

Siu

Fowler

et al. 2020

Pilot Feasibility Stud

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Background: Dry mouth is a common perioperative patient complaint. There are a number of treatments used for dry mouth in other settings which are effective. None have been tested previously in the perioperative setting. Interventions to Manage Dry mouth (IM DRY) compared the effect of water and a saliva substitute on mouth dryness. The primary objective was to demonstrate the feasibility of conducting a large randomised controlled trial and secondary scientific aims were to assess treatment potential efficacy. Methods: Single blind, pilot randomised controlled trial (RCT) of 101 pre-operative elective surgical patients who were randomised to water or saliva substitute (Biotene oral rinse, GlaxoSmithKline, Australia) at a tertiary, university hospital. Dry mouth was assessed by 100 mm visual analogue scale (VAS) and 5-point Likert score. Results: One hundred participants completed follow-up and comprised the analysis dataset. All feasibility outcomes were achieved (recruitment rate > 5 participants a week, >95% completeness of the dataset, study protocol acceptability to staff, acceptability to participants > 66% and adherence to time limits within the protocol). Mean recruitment rate was 6 participants per week. These data were 99% complete. There were no adverse side effects or complications noted. There were no concerns raised by staff regarding acceptability. Overall, there was a mean of 30 min (± SD 5 min) between delivery of the intervention and the assessment, 30 min being the target time. The difference in VAS post intervention was − 11.2 mm (95% CI − 17.3 to − 5.1 mm) for water and − 12.7 mm (95% CI − 18.7 to − 6.7 mm) for saliva substitute. The proportion of patients who had improved dry mouth increased from 52% for water to 62% for saliva substitute. Conclusions: IM DRY successfully achieved its primary feasibility aims: recruitment rate, completeness of these, acceptability and protocol adherence. Saliva substitutes, used in the perioperative management of dry mouth, may be a simple, inexpensive, and low risk solution to help alleviate this common complaint. A large randomised controlled trial is feasible and is currently recruiting (ANZCTR 12619000132145).

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“…Em estudo realizado por Zmijewska-Tomczak et al 2014 (Amerongen e Veerman, 2003;Braga et al, 2009;Castro Junior e Federico, 2006;Salom et al, 2015;Wong et al, 2015;Gil-Montoya et al, 2016).…”

Section: Qualidade De Vidaunclassified

“…ii) géis orais (Colgate-Base e Crest); iii) colutórios (Biotene, Oral Balance e Zendium); iv) preparações caseiras (solução salina (NaCl 0,9%), limão e solução de bicarbonato); e por substitutos da saliva (Glandosane, Xerolube e Orex Saliment) (Amerongen e Veerman, 2003;Braga et al, 2009;Salom et al, 2015;Gil-Montoya et al, 2016).…”

Section: Qualidade De Vidaunclassified

Efeito de uma formulação farmacêutica de pilocarpina em pacientes com xerostomia: estudo randomizado, controlado, duplo-cego e <i>crossover</i>

Pereira¹

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Efficacy and safety of a new oral saliva equivalent in the management of xerostomia: a national, multicenter, randomized study

Cited by 19 publications

References 27 publications

Efficacy of artificial salivary substitutes in treatment of xerostomia: A systematic review

Efficacy of artificial salivary substitutes in treatment of xerostomia: A systematic review

A randomised controlled pilot trial of two interventions to manage dry mouth in pre-operative elective surgical patients

Efeito de uma formulação farmacêutica de pilocarpina em pacientes com xerostomia: estudo randomizado, controlado, duplo-cego e <i>crossover</i>

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