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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Department of Oral Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Study Director: Joke Duyck, DDS, PhD, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Estimate): April 13, 2016
• Last Update Submitted That Met QC Criteria: April 7, 2016
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: patients; edentulous; with full
• Other Study ID Numbers: S56279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO