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临床试验/NCT02454413
NCT02454413已完成不适用

ASSESSMENT OF THE IMPACT OF CLEANING METHODS AND OVERNIGHT DENTURE STORAGE ON BIOFILM FORMATION ON REMOVABLE ACRYLIC DENTURES.

Universitaire Ziekenhuizen KU Leuven0 个研究点目标入组 13 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
主要终点
Biofilm (quantity and quality) on the removable acrylic denture

研究概览

简要总结

Clinical guidelines for denture care are available, but evidence for optimal nocturnal storage is missing. The investigators (Duyck J., Vandamme K., Teughels W.) therefore performed a study (submitted for publication) to evaluate the effect of different overnight storage protocols on denture biofilm formation and maturation. The results of this study showed that the use of cleansing tablets (Corega Tabs Anti-bacteria®, GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium) for acrylic removable denture overnight storage reduces denture biofilm mass and pathogenicity compared to dry and water preservation. As no mechanical denture cleaning was performed in the aforementioned study, the aim of the proposed study is to evaluate the combined effect of mechanical cleaning and overnight storage condition on the microbial composition and Candida albicans colonization of denture biofilm formation. This information is required to develop a clinical guideline on acrylic denture cleaning and overnight storage aiming to reduce the risk posed by pathogenic microorganisms, particularly in bedridden and immunocompromised patients.

It is hypothetised that mechanical denture cleaning will decrease the impact of overnight denture storage condition on biofilm formation on acrylic removable dentures.

详细描述

Aim of the study

The presence of a biofilm - i.e. structured microbial communities that are attached to a surface and encased in an exopolymer matrix - on acrylic removable dentures has been associated with serious systemic conditions, especially in the dependent elderly [1]. Oral bacteria have been implicated in bacterial endocarditis [2], aspiration pneumonia [3, 4], chronic obstructive pulmonary disease [5, 6], amongst other diseases [1, 7]. Ample evidence is provided regarding the relationship between proper oral hygiene and overall systemic health.

Plaque on dentures is a complex aggregate containing more than 108 organisms per milligram, and involving more than 600 prokaryote species [8]. The different species collaborate to form a symbiotic biofilm. The biofilms in dentate patients have been studied extensively, but there have been few studies on the biofilm microbiota of complete acrylic dentures [10-18]. It appears that distinct biofilms, with associated pathogenic risks, are present in 'healthy' versus denture stomatitis affected participants [15, 16, 18]. Not only poor denture cleaning but also inappropriate habits, such as wearing dentures overnight have proved to be associated with the prevalence of Candida-associated stomatitis [19, 20]. Therefore, the overnight removal of the acrylic removable dentures is advised in clinical settings. Although evidence-based guidelines for denture care and maintenance are available [21], guidelines for nocturnal storage conditions of dentures are missing. The investigators therefore performed a study (submitted for publication) to evaluate the effect of different overnight storage protocols on denture biofilm formation and maturation. The results of this study showed that the use of cleansing tablets (Corega Tabs Anti-bacteria®, GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium) for acrylic removable denture overnight storage reduces denture biofilm mass and pathogenicity compared to dry and water preservation.

As no mechanical denture cleaning was performed in the aforementioned study, the aim of the proposed study is to evaluate the combined effect of mechanical cleaning and overnight storage condition on the microbial composition and Candida albicans colonization of denture biofilm formation. This information is required to develop a clinical guideline on acrylic denture cleaning and overnight storage aiming to reduce the risk posed by pathogenic microorganisms, particularly in bedridden and immunocompromised patients.

Research questions

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Institutionalised frail elder
  • Fully edentulous in lower and upper jaw
  • Removable denture wearer in lower and upper jaw
  • Good oral health

排除标准

  • Current or history of corticosteroid treatment within the 3 months prior to the study
  • Current or history of antimicrobial treatment within the 3 months prior to the study
  • Inability to provide informed consent
  • Inability to comply with the study requirements

结局指标

主要结局

Biofilm (quantity and quality) on the removable acrylic denture

时间窗: sample taken at day 5 of the test period

次要结局

  • Oral health status(oral health control at day 5 of the test period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joke Duyck

Professor

Universitaire Ziekenhuizen KU Leuven

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