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

Mandibular Prosthesis User Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736994
• Other study ID #: S56279
• Status: Completed
• Phase: N/A
• First received: January 17, 2014
• Last updated: April 7, 2016
• Start date: April 2014
• Est. completion date: September 2014

Study information

• Verified date: November 2013
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Mandibular Prosthesis User

Intervention

Drug:
• PIP toothbrush cleaner® (Chrisal, Lommel, Belgium).
Probiotic
• Corega Tabs Anti-bacteria®
Cleansing tablet -Corega Tabs Anti-bacteria® (GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium)

Other:
• Water
Water

Locations

Country	Name	City	State
Belgium	Department of Oral Health Sciences	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Other microbiological counts Aa	The concentration of Aggregatibacter Actinomycetemcomitans was researched.	day 5	No
Secondary	Other microbiological counts Pg	The concentration of Porphyromonas gingivalis was researched.	day 5	No
Secondary	Other microbiological counts Tf	The concentration of Tannerella forsythensis was researched.	day 5	No
Secondary	Other microbiological counts Td	The concentration of Treponema denticola was researched.	day 5	No
Secondary	Other microbiological counts Pi	The concentration of Prevotella intermedia was researched.	day 5	No
Secondary	Other microbiological counts Fn	The concentration of Fusobacterium nucleatum was researched.	day 5	No
Secondary	Other microbiological counts Pm	The concentration of Peptostreptococcus micros was researched.	day 5	No
Secondary	Other microbiological counts Pn	The concentration of Prevotella nigrescens was researched.	day 5	No
Secondary	Other microbiological counts Cg	The concentration of Campylobacter gracilis was researched.	day 5	No
Secondary	Other microbiological counts Cr	The concentration of Campylobacter rectus was researched.	day 5	No
Secondary	Other microbiological counts En	The concentration of Eubacterium nodatum was researched.	day 5	No
Secondary	Other microbiological counts Ec	The concentration of Eikenella corrodens was researched.	day 5	No
Secondary	Other microbiological counts Capn	The concentration of Capnocytophaga species was researched.	day 5	No
Secondary	Other microbiological counts Cc	The concentration of Campylobacter concisus count was researched.	day 5	No
Secondary	Other microbiological counts mitis streptococci	Concentration of mitis streptococci	day 5	No
Secondary	Other microbiological counts Sg	The concentration of Streptococcus gordonii	day 5	No
Secondary	Other microbiological counts Sc	The concentration of Streptococcus constellatus.	day 5	No
Secondary	Other microbiological counts Ao	The concentration of Actinomyces odontolyticus.	day 5	No
Secondary	Other microbiological counts Av	The concentration of Actinomyces viscosus.	day 5	No
Secondary	Other microbiological counts Vp	The concentration of Veillonella parvula.	day 5	No
Secondary	Other microbiological counts total	Total bacterial count.	day 5	No