NCT04247438: KÜBI

Dentures Biofilm and Artificial Biofilm Substitute

Completed NA Last updated 3 December 2021

What this trial tests

NA trial testing 12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it. in Biofilm in 8 participants. Completed in 31 December 2020.

Timeline

2 March 2020

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Technische Universität Dresden
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	8
Start date	2 March 2020
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across Germany

Drugs / interventions tested

• 12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it.

Conditions studied

• Biofilm — all drugs for Biofilm →

Sponsor

Technische Universität Dresden — full company profile →

Who can join

18 and older, any sex, with Biofilm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The biofilm on oral surfaces can lead to oral diseases. The correlation between oral biofilm and diseases and general health is well known. Therefore, cleaning of teeth or dentures from biofilm is essential for the maintenance of oral and general health. Currently, the society is ageing, the number of elderly as well as home and institutionalized care patients is increasing. In particular, these suffer from higher tooth loss, wear removable dentures and have problems with independent oral and denture hygiene. Therefore, support from well-trained nursing staff or family members is important. The use of suitable artificial biofilm substitutes may be helpful, in order to efficiently and easily perform oral and denture hygiene education, as well as to carry out laboratory tests of oral and denture hygiene products. The absence of such appropriate substitutes for denture biofilm requires innovations in this field. The aim of this pilot study is to verify the feasibility of the study protocol, design and methods. Additionally, an innovative artificial biofilm substitute based on polysaccharides will be further developed. This pilot study includes five study parts. Two in vivo examinations and three in vitro tests. This pilot study creates the basis for further main studies and implements the development of validated artificial biofilm substitutes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.