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

Not Applicable

Completed

• Conditions: Mandibular Prosthesis User
• Interventions: Drug: Corega Tabs Anti-bacteria®; Drug: PIP toothbrush cleaner® (Chrisal, Lommel, Belgium).; Other: Water

• Registration Number: NCT02736994
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Status Verified: 2013-11
• Study First Submitted: 2014-01-17
• Study Start: 2014-04
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Study First Submitted QC: 2016-04-07
• Last Update Submitted: 2016-04-07
• Study First Posted: 2016-04-13
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immersion in water + cleansing tablet	Corega Tabs Anti-bacteria®	Corega Tabs Anti-bacteria® (GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium)
Immersion in water with PIP	PIP toothbrush cleaner® (Chrisal, Lommel, Belgium).	PIP toothbrush cleaner® (Chrisal, Lommel, Belgium)
Immersion in water	Water	water

Primary Outcome Measures

Name	Time	Method
Candida albicans colonization	day 5	C. albicans colonization was the primary outcome measure of interest. With a microbial test there was researched if C. albicans colonized the prostheses.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Oral Health Sciences; 🇧🇪 Leuven, Belgium