Assessment of the Impact of Probiotics on Biofilm Formation on Removable Acrylic Dentures

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effect of PIP toothbrush cleaner® on the microbial composition and Candida albicans colonization of denture biofilm formation. Additionally, its effect will be compared to that of cleansing tablets.

Detailed Description
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Therefore the present study intended to compare a probiotic denture cleaning protocol with the current protocols. It was aimed to examine, in institutionalized older individuals with removable complete dentures, if the microbial composition and C. albicans colonization of the denture biofilm differs when overnight stored in a probiotic cleaning product compared to water or a cleanser. Additionally the influence of brushing on these protocols was investigated.

Official Title
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Assessment of the Impact of Probiotics on Biofilm Formation on Removable Acrylic Dentures

Conditions
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Mandibular Prosthesis User

Intervention / Treatment
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* Drug: PIP toothbrush cleaner® (Chrisal, Lommel, Belgium).
* Drug: Corega Tabs Anti-bacteria®
* Other: Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Reside in a home for elderly Fully edentulous in lower and upper jaw Removable denture wearer in lower and upper jaw Good oral health Exclusion Criteria: 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 Heart disorders persons with a high risk for an unfavourable prognosis of bacterial endocarditis will be excluded. This applies to patients with prosthetic heart valves, history of infectious endocarditis, cyanogenic congenital heart disorders (including palliative shunts and connections), completely recovered congenital disorders that were treated less than 6 months ago, treated congenital heart disorders with residual defect, and valvulopathy after heart transplantation.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Immersion in water<br>water | Other: Water<br>* Water<br>|
| Active Comparator: Immersion in water + cleansing tablet<br>Corega Tabs Anti-bacteria® (GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium) | Drug: Corega Tabs Anti-bacteria®<br>* Cleansing tablet -Corega Tabs Anti-bacteria® (GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium)<br>* Other names: Cleansing tablet;|
| Experimental: Immersion in water with PIP<br>PIP toothbrush cleaner® (Chrisal, Lommel, Belgium) | Drug: PIP toothbrush cleaner® (Chrisal, Lommel, Belgium).<br>* Probiotic<br>* Other names: Probiotic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Candida albicans colonization | C. albicans colonization was the primary outcome measure of interest. With a microbial test there was researched if C. albicans colonized the prostheses. | day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other microbiological counts Aa | The concentration of Aggregatibacter Actinomycetemcomitans was researched. | day 5 | 
| Other microbiological counts Pg | The concentration of Porphyromonas gingivalis was researched. | day 5 | 
| Other microbiological counts Tf | The concentration of Tannerella forsythensis was researched. | day 5 | 
| Other microbiological counts Td | The concentration of Treponema denticola was researched. | day 5 | 
| Other microbiological counts Pi | The concentration of Prevotella intermedia was researched. | day 5 | 
| Other microbiological counts Fn | The concentration of Fusobacterium nucleatum was researched. | day 5 | 
| Other microbiological counts Pm | The concentration of Peptostreptococcus micros was researched. | day 5 | 
| Other microbiological counts Pn | The concentration of Prevotella nigrescens was researched. | day 5 | 
| Other microbiological counts Cg | The concentration of Campylobacter gracilis was researched. | day 5 | 
| Other microbiological counts Cr | The concentration of Campylobacter rectus was researched. | day 5 | 
| Other microbiological counts En | The concentration of Eubacterium nodatum was researched. | day 5 | 
| Other microbiological counts Ec | The concentration of Eikenella corrodens was researched. | day 5 | 
| Other microbiological counts Capn | The concentration of Capnocytophaga species was researched. | day 5 | 
| Other microbiological counts Cc | The concentration of Campylobacter concisus count was researched. | day 5 | 
| Other microbiological counts mitis streptococci | Concentration of mitis streptococci | day 5 | 
| Other microbiological counts Sg | The concentration of Streptococcus gordonii | day 5 | 
| Other microbiological counts Sc | The concentration of Streptococcus constellatus. | day 5 | 
| Other microbiological counts Ao | The concentration of Actinomyces odontolyticus. | day 5 | 
| Other microbiological counts Av | The concentration of Actinomyces viscosus. | day 5 | 
| Other microbiological counts Vp | The concentration of Veillonella parvula. | day 5 | 
| Other microbiological counts total | Total bacterial count. | day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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edentulous, patients, with full