Clinical trial NCT02736994: Assessment of the Impact of Probiotics on Biofilm Formation on Removable Acrylic Dentures
Official title: Assessment of the Impact of Probiotics on Biofilm Formation on Removable Acrylic Dentures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Prosthesis User
Keywords: edentulous
patients
with full
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Candida albicans colonization
timeFrame: day 5
Secondary outcomes:
measure: Other microbiological counts Aa
timeFrame: day 5
measure: Other microbiological counts Pg
timeFrame: day 5
measure: Other microbiological counts Tf
timeFrame: day 5
measure: Other microbiological counts Td
timeFrame: day 5
measure: Other microbiological counts Pi
timeFrame: day 5
measure: Other microbiological counts Fn
timeFrame: day 5
measure: Other microbiological counts Pm
timeFrame: day 5
measure: Other microbiological counts Pn
timeFrame: day 5
measure: Other microbiological counts Cg
timeFrame: day 5
measure: Other microbiological counts Cr
timeFrame: day 5
measure: Other microbiological counts En
timeFrame: day 5
measure: Other microbiological counts Ec
timeFrame: day 5
measure: Other microbiological counts Capn
timeFrame: day 5
measure: Other microbiological counts Cc
timeFrame: day 5
measure: Other microbiological counts mitis streptococci
timeFrame: day 5
measure: Other microbiological counts Sg
timeFrame: day 5
measure: Other microbiological counts Sc
timeFrame: day 5
measure: Other microbiological counts Ao
timeFrame: day 5
measure: Other microbiological counts Av
timeFrame: day 5
measure: Other microbiological counts Vp
timeFrame: day 5
measure: Other microbiological counts total
timeFrame: day 5
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Oral Health Sciences
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Joke Duyck, DDS, PhD
role: STUDY_DIRECTOR
References:
citation: Duyck J, Vandamme K, Muller P, Teughels W. Overnight storage of removable dentures in alkaline peroxide-based tablets affects biofilm mass and composition. J Dent. 2013 Dec;41(12):1281-9. doi: 10.1016/j.jdent.2013.08.002. Epub 2013 Aug 13.