Mandibular Prosthesis UserNCT02736994
Assessment of the Impact of Probiotics on Biofilm Formation on Removable Acrylic Dentures
A study testing PIP toothbrush cleaner® (Chrisal, Lommel, Belgium)., Corega Tabs Anti-bacteria® and Water in people with Mandibular Prosthesis User, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mandibular Prosthesis User
- What is being tested?
- PIP toothbrush cleaner® (Chrisal, Lommel, Belgium)., Corega Tabs Anti-bacteria® and Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Reside in a home for elderly
- Fully edentulous in lower and upper jaw
- Removable denture wearer in lower and upper jaw
- Good oral health
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mandibular Prosthesis User
- Being tested
- PIP toothbrush cleaner® (Chrisal, Lommel, Belgium)., Corega Tabs Anti-bacteria®, Water
- Keywords
- edentulous, patients, with full
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIP toothbrush cleaner® (Chrisal, Lommel, Belgium).Drug
Also called Probiotic
Probiotic
Corega Tabs Anti-bacteria®Drug
Also called Cleansing tablet
Cleansing tablet -Corega Tabs Anti-bacteria® (GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium)
WaterOther
Water
| Study group | Role | What they receive |
|---|---|---|
| Immersion in water | Other | water Receives: Other: Water |
| Immersion in water + cleansing tablet | Active comparator | Corega Tabs Anti-bacteria® (GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium) Receives: Drug: Corega Tabs Anti-bacteria® |
| Immersion in water with PIP | Experimental | PIP toothbrush cleaner® (Chrisal, Lommel, Belgium) Receives: Drug: PIP toothbrush cleaner® (Chrisal, Lommel, Belgium). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Candida albicans colonization
- albicans colonization was the primary outcome measure of interest. With a microbial test there was researched if C. albicans colonized the prostheses.
Measured: day 5
Secondary outcomes (21)
Other microbiological counts Aa
The concentration of Aggregatibacter Actinomycetemcomitans was researched.
Measured: day 5
Other microbiological counts Pg
The concentration of Porphyromonas gingivalis was researched.
Measured: day 5
Other microbiological counts Tf
The concentration of Tannerella forsythensis was researched.
Measured: day 5
Other microbiological counts Td
The concentration of Treponema denticola was researched.
Measured: day 5
Other microbiological counts Pi
The concentration of Prevotella intermedia was researched.
Measured: day 5
Other microbiological counts Fn
The concentration of Fusobacterium nucleatum was researched.
Measured: day 5
Other microbiological counts Pm
The concentration of Peptostreptococcus micros was researched.
Measured: day 5
Other microbiological counts Pn
The concentration of Prevotella nigrescens was researched.
Measured: day 5
Other microbiological counts Cg
The concentration of Campylobacter gracilis was researched.
Measured: day 5
Other microbiological counts Cr
The concentration of Campylobacter rectus was researched.
Measured: day 5
Other microbiological counts En
The concentration of Eubacterium nodatum was researched.
Measured: day 5
Other microbiological counts Ec
The concentration of Eikenella corrodens was researched.
Measured: day 5
Other microbiological counts Capn
The concentration of Capnocytophaga species was researched.
Measured: day 5
Other microbiological counts Cc
The concentration of Campylobacter concisus count was researched.
Measured: day 5
Other microbiological counts mitis streptococci
Concentration of mitis streptococci
Measured: day 5
Other microbiological counts Sg
The concentration of Streptococcus gordonii
Measured: day 5
Other microbiological counts Sc
The concentration of Streptococcus constellatus.
Measured: day 5
Other microbiological counts Ao
The concentration of Actinomyces odontolyticus.
Measured: day 5
Other microbiological counts Av
The concentration of Actinomyces viscosus.
Measured: day 5
Other microbiological counts Vp
The concentration of Veillonella parvula.
Measured: day 5
Other microbiological counts total
Total bacterial count.
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mandibular Prosthesis UserStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joke Duyck, DDS, PhD, Study director, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736994
- Sponsor's protocol ID
- S56279
- Status last verified
- Nov 2013
- First submitted
- 17 Jan 2014
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 23948391
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Probiotics on Biofilm Formation on Removable Acrylic Dentures
- ClinicalTrials.gov ID
- NCT02736994
- Acronym / sponsor ID
- S56279
- Conditions
- Mandibular Prosthesis User
- Keywords
- edentulous, patients, with full
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immersion in water | Other | Other: Waterwater |
| Immersion in water + cleansing tablet | Active comparator | Drug: Corega Tabs Anti-bacteria®Corega Tabs Anti-bacteria® (GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium) |
| Immersion in water with PIP | Experimental | Drug: PIP toothbrush cleaner® (Chrisal, Lommel, Belgium).PIP toothbrush cleaner® (Chrisal, Lommel, Belgium) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Reside in a home for elderly
- Fully edentulous in lower and upper jaw
- Removable denture wearer in lower and upper jaw
- Good oral health
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIP toothbrush cleaner® (Chrisal, Lommel, Belgium).Also: ProbioticProbiotic | Drug | Immersion in water with PIP |
| Corega Tabs Anti-bacteria®Also: Cleansing tabletCleansing tablet -Corega Tabs Anti-bacteria® (GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium) | Drug | Immersion in water + cleansing tablet |
| WaterWater | Other | Immersion in water |
Primary outcome
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.
21 secondary outcomes
Other microbiological counts Aa
Time frame: day 5
Other microbiological counts Pg
Time frame: day 5
Other microbiological counts Tf
Time frame: day 5
Other microbiological counts Td
Time frame: day 5
Other microbiological counts Pi
Time frame: day 5
Other microbiological counts Fn
Time frame: day 5
Other microbiological counts Pm
Time frame: day 5
Other microbiological counts Pn
Time frame: day 5
Other microbiological counts Cg
Time frame: day 5
Other microbiological counts Cr
Time frame: day 5
Other microbiological counts En
Time frame: day 5
Other microbiological counts Ec
Time frame: day 5
Other microbiological counts Capn
Time frame: day 5
Other microbiological counts Cc
Time frame: day 5
Other microbiological counts mitis streptococci
Time frame: day 5
Other microbiological counts Sg
Time frame: day 5
Other microbiological counts Sc
Time frame: day 5
Other microbiological counts Ao
Time frame: day 5
Other microbiological counts Av
Time frame: day 5
Other microbiological counts Vp
Time frame: day 5
Other microbiological counts total
Time frame: day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Background: PubMed 23948391Duyck 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joke Duyck, DDS, PhD study director
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIP toothbrush cleaner® (Chrisal, Lommel, Belgium)., Corega Tabs Anti-bacteria® and Water in people with Mandibular Prosthesis User, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Candida albicans colonization (time frame: day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02736994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.