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

April 7, 2016 updated by: Universitaire Ziekenhuizen KU Leuven
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
day 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Other microbiological counts Aa
Time Frame: day 5
The concentration of Aggregatibacter Actinomycetemcomitans was researched.
day 5
Other microbiological counts Pg
Time Frame: day 5
The concentration of Porphyromonas gingivalis was researched.
day 5
Other microbiological counts Tf
Time Frame: day 5
The concentration of Tannerella forsythensis was researched.
day 5
Other microbiological counts Td
Time Frame: day 5
The concentration of Treponema denticola was researched.
day 5
Other microbiological counts Pi
Time Frame: day 5
The concentration of Prevotella intermedia was researched.
day 5
Other microbiological counts Fn
Time Frame: day 5
The concentration of Fusobacterium nucleatum was researched.
day 5
Other microbiological counts Pm
Time Frame: day 5
The concentration of Peptostreptococcus micros was researched.
day 5
Other microbiological counts Pn
Time Frame: day 5
The concentration of Prevotella nigrescens was researched.
day 5
Other microbiological counts Cg
Time Frame: day 5
The concentration of Campylobacter gracilis was researched.
day 5
Other microbiological counts Cr
Time Frame: day 5
The concentration of Campylobacter rectus was researched.
day 5
Other microbiological counts En
Time Frame: day 5
The concentration of Eubacterium nodatum was researched.
day 5
Other microbiological counts Ec
Time Frame: day 5
The concentration of Eikenella corrodens was researched.
day 5
Other microbiological counts Capn
Time Frame: day 5
The concentration of Capnocytophaga species was researched.
day 5
Other microbiological counts Cc
Time Frame: day 5
The concentration of Campylobacter concisus count was researched.
day 5
Other microbiological counts mitis streptococci
Time Frame: day 5
Concentration of mitis streptococci
day 5
Other microbiological counts Sg
Time Frame: day 5
The concentration of Streptococcus gordonii
day 5
Other microbiological counts Sc
Time Frame: day 5
The concentration of Streptococcus constellatus.
day 5
Other microbiological counts Ao
Time Frame: day 5
The concentration of Actinomyces odontolyticus.
day 5
Other microbiological counts Av
Time Frame: day 5
The concentration of Actinomyces viscosus.
day 5
Other microbiological counts Vp
Time Frame: day 5
The concentration of Veillonella parvula.
day 5
Other microbiological counts total
Time Frame: day 5
Total bacterial count.
day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Joke Duyck, DDS, PhD, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S56279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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