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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02736994
Enrollment
13
Registered
2016-04-13
Start date
2014-04-30
Completion date
2014-09-30
Last updated
2016-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular Prosthesis User

Keywords

edentulous, patients, with full

Brief summary

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

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.

Interventions

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

Probiotic

DRUGCorega Tabs Anti-bacteria®

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

OTHERWater

Water

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Candida albicans colonizationday 5C. albicans colonization was the primary outcome measure of interest. With a microbial test there was researched if C. albicans colonized the prostheses.

Secondary

MeasureTime frameDescription
Other microbiological counts Crday 5The concentration of Campylobacter rectus was researched.
Other microbiological counts Enday 5The concentration of Eubacterium nodatum was researched.
Other microbiological counts Ecday 5The concentration of Eikenella corrodens was researched.
Other microbiological counts Capnday 5The concentration of Capnocytophaga species was researched.
Other microbiological counts Ccday 5The concentration of Campylobacter concisus count was researched.
Other microbiological counts Aaday 5The concentration of Aggregatibacter Actinomycetemcomitans was researched.
Other microbiological counts Pgday 5The concentration of Porphyromonas gingivalis was researched.
Other microbiological counts Tfday 5The concentration of Tannerella forsythensis was researched.
Other microbiological counts Tdday 5The concentration of Treponema denticola was researched.
Other microbiological counts Piday 5The concentration of Prevotella intermedia was researched.
Other microbiological counts Cgday 5The concentration of Campylobacter gracilis was researched.
Other microbiological counts Pmday 5The concentration of Peptostreptococcus micros was researched.
Other microbiological counts Pnday 5The concentration of Prevotella nigrescens was researched.
Other microbiological counts mitis streptococciday 5Concentration of mitis streptococci
Other microbiological counts Sgday 5The concentration of Streptococcus gordonii
Other microbiological counts Scday 5The concentration of Streptococcus constellatus.
Other microbiological counts Aoday 5The concentration of Actinomyces odontolyticus.
Other microbiological counts Avday 5The concentration of Actinomyces viscosus.
Other microbiological counts Vpday 5The concentration of Veillonella parvula.
Other microbiological counts totalday 5Total bacterial count.
Other microbiological counts Fnday 5The concentration of Fusobacterium nucleatum was researched.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026