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

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ClinicalTrials.gov Identifier: NCT02736994
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen 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.

Condition or disease Intervention/treatment Phase
Mandibular Prosthesis User Drug: PIP toothbrush cleaner® (Chrisal, Lommel, Belgium). Drug: Corega Tabs Anti-bacteria® Other: Water Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Assessment of the Impact of Probiotics on Biofilm Formation on Removable Acrylic Dentures
Study Start Date : April 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
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 Name: Cleansing tablet

Experimental: Immersion in water with PIP
PIP toothbrush cleaner® (Chrisal, Lommel, Belgium)
Drug: PIP toothbrush cleaner® (Chrisal, Lommel, Belgium).
Probiotic
Other Name: Probiotic




Primary Outcome Measures :
  1. Candida albicans colonization [ Time Frame: 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 :
  1. Other microbiological counts Aa [ Time Frame: day 5 ]
    The concentration of Aggregatibacter Actinomycetemcomitans was researched.

  2. Other microbiological counts Pg [ Time Frame: day 5 ]
    The concentration of Porphyromonas gingivalis was researched.

  3. Other microbiological counts Tf [ Time Frame: day 5 ]
    The concentration of Tannerella forsythensis was researched.

  4. Other microbiological counts Td [ Time Frame: day 5 ]
    The concentration of Treponema denticola was researched.

  5. Other microbiological counts Pi [ Time Frame: day 5 ]
    The concentration of Prevotella intermedia was researched.

  6. Other microbiological counts Fn [ Time Frame: day 5 ]
    The concentration of Fusobacterium nucleatum was researched.

  7. Other microbiological counts Pm [ Time Frame: day 5 ]
    The concentration of Peptostreptococcus micros was researched.

  8. Other microbiological counts Pn [ Time Frame: day 5 ]
    The concentration of Prevotella nigrescens was researched.

  9. Other microbiological counts Cg [ Time Frame: day 5 ]
    The concentration of Campylobacter gracilis was researched.

  10. Other microbiological counts Cr [ Time Frame: day 5 ]
    The concentration of Campylobacter rectus was researched.

  11. Other microbiological counts En [ Time Frame: day 5 ]
    The concentration of Eubacterium nodatum was researched.

  12. Other microbiological counts Ec [ Time Frame: day 5 ]
    The concentration of Eikenella corrodens was researched.

  13. Other microbiological counts Capn [ Time Frame: day 5 ]
    The concentration of Capnocytophaga species was researched.

  14. Other microbiological counts Cc [ Time Frame: day 5 ]
    The concentration of Campylobacter concisus count was researched.

  15. Other microbiological counts mitis streptococci [ Time Frame: day 5 ]
    Concentration of mitis streptococci

  16. Other microbiological counts Sg [ Time Frame: day 5 ]
    The concentration of Streptococcus gordonii

  17. Other microbiological counts Sc [ Time Frame: day 5 ]
    The concentration of Streptococcus constellatus.

  18. Other microbiological counts Ao [ Time Frame: day 5 ]
    The concentration of Actinomyces odontolyticus.

  19. Other microbiological counts Av [ Time Frame: day 5 ]
    The concentration of Actinomyces viscosus.

  20. Other microbiological counts Vp [ Time Frame: day 5 ]
    The concentration of Veillonella parvula.

  21. Other microbiological counts total [ Time Frame: day 5 ]
    Total bacterial count.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736994


Locations
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Belgium
Department of Oral Health Sciences
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Study Director: Joke Duyck, DDS, PhD Universitaire Ziekenhuizen Leuven

Publications:
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02736994     History of Changes
Other Study ID Numbers: S56279
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: November 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
edentulous
patients
with full