NCT02736994

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
Last Updated

April 13, 2016

Status Verified

November 1, 2013

Enrollment Period

5 months

First QC Date

January 17, 2014

Last Update Submit

April 7, 2016

Conditions

Mandibular Prosthesis User

Keywords

edentulouspatientswith full

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (21)

  • Other microbiological counts Aa

    day 5

  • Other microbiological counts Pg

    day 5

  • Other microbiological counts Tf

    day 5

  • Other microbiological counts Td

    day 5

  • Other microbiological counts Pi

    day 5

  • +16 more secondary outcomes

Study Arms (3)

Immersion in water

OTHER

water

Other: Water

Immersion in water + cleansing tablet

ACTIVE COMPARATOR

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

Drug: Corega Tabs Anti-bacteria®

Immersion in water with PIP

EXPERIMENTAL

PIP toothbrush cleaner® (Chrisal, Lommel, Belgium)

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

Interventions

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

Probiotic

Also known as: Probiotic
Immersion in water with PIP
Corega Tabs Anti-bacteria®DRUG

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

Also known as: Cleansing tablet
Immersion in water + cleansing tablet
WaterOTHER

Water

Immersion in water

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Reside in a home for elderly
  • Fully edentulous in lower and upper jaw
  • Removable denture wearer in lower and upper jaw
  • Good oral health

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oral Health Sciences

Leuven, 3000, Belgium

Location

Related 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.

    PMID: 23948391BACKGROUND

MeSH Terms

Conditions

Mouth, Edentulous

Interventions

ProbioticsWater

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Joke Duyck, DDS, PhD

    Universitaire Ziekenhuizen KU Leuven

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2014

First Posted

April 13, 2016

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 13, 2016

Record last verified: 2013-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)