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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-09-30

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.

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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.

Conditions

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Mandibular Prosthesis User

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Immersion in water

water

Group Type OTHER

Water

Intervention Type OTHER

Water

Immersion in water + cleansing tablet

Corega Tabs Anti-bacteria® (GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium)

Group Type ACTIVE_COMPARATOR

Corega Tabs Anti-bacteria®

Intervention Type DRUG

Cleansing tablet -Corega Tabs Anti-bacteria® (GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium)

Immersion in water with PIP

PIP toothbrush cleaner® (Chrisal, Lommel, Belgium)

Group Type EXPERIMENTAL

PIP toothbrush cleaner® (Chrisal, Lommel, Belgium).

Intervention Type DRUG

Probiotic

Interventions

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PIP toothbrush cleaner® (Chrisal, Lommel, Belgium).

Probiotic

Intervention Type DRUG

Corega Tabs Anti-bacteria®

Cleansing tablet -Corega Tabs Anti-bacteria® (GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium)

Intervention Type DRUG

Water

Intervention Type OTHER

Other Intervention Names

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Probiotic Cleansing tablet

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes