CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it.other
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04247438
NCT04247438N/ACompleted

Polysaccharide-based, Artificial Biofilm Substitute - Clinical Pilot Study for Validation Process

Technische Universität Dresden·interventional·Posted Jan 30, 2020·Updated Dec 3, 2021

In Brief

A clinical study evaluating 12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it. for Biofilm. Completed, enrolled 8 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiofilm
CountriesGermany

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 30, 2020
Enrollment StartMar 2, 2020
Primary CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.4 years ago

Interventions

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

Capturing the clinical data for biofilm formation on PMMA dentures and samples worn by participants and the number of brushing cycles required to remove this biofilm. Development of artificial denture biofilm substitute with similar mechanical properties to real denture biofilm.