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Completed

NCT Number: NCT02736994

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.

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Key information

Conditions

Mandibular Prosthesis User Mouth Diseases Mouth, Edentulous Stomatognathic Diseases Tooth Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oral Health Sciences

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PIP toothbrush cleaner® (Chrisal, Lommel, Belgium).

Drug

Probiotic

Other names: Probiotic

Corega Tabs Anti-bacteria®

Drug

Cleansing tablet -Corega Tabs Anti-bacteria® (GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium)

Other names: Cleansing tablet

Water

Other

Water

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 13, 2016
Registry last updated
Apr 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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