Clinical trial NCT04247438: Dentures Biofilm and Artificial Biofilm Substitute
Official title: Polysaccharide-based, Artificial Biofilm Substitute - Clinical Pilot Study for Validation Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biofilm
Keywords: dental biofilm
dental plaque
polysaccharides
chitosan
methylcellulose
denture biofilm
denture plaque
biofilm model
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2020-01-30
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, prospective, longitudinal, interventional pilot study to test the feasibility of study design, protocol, and methods for evaluating the artificial dentures biofilm equivalent. This pilot study is intended to provide initial data and insights into the development and establishment of an artificial dentures biofilm equivalent. According to the current state of research, no data, therefore, are available.
Primary purpose: OTHER

Brief 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.

Detailed description: The bacterial biofilm on the intraoral surfaces is a three-dimensionally structured, firmly adhering layer of microorganisms surrounded by a matrix of extracellular polymeric substances (EPS). This matrix can take up to 90% of the biofilm mass. Biofilm on oral surfaces can lead to diseases such as caries, periodontitis or denture stomatitis. Furthermore, an association between denture biofilm, which serves as a reservoir for various bacteria, and general diseases is described. Adequate denture hygiene is therefore essential for maintaining the health of denture wearers. Nevertheless, adequate oral and denture hygiene is not sufficiently available for many, especially institutionalized elderly. The reasons are mostly insufficient preventive measures to train denture wearers, nursing staff and family members, as well as a lack of training materials such as dentures with artificial biofilm equivalents, which have the same cleaning properties as real dentures biofilm.

The absence of such appropriate substitutes for denture biofilm requires innovations in this field. Further, clinical data for validation of innovative artificial biofilm substitutes are missing.

The aim of this pilot study is to carry out preliminary tests for the development of a polysaccharide-based artificial biofilm substitute to simulate the real denture biofilm and to verify the feasibility of the study protocol, design and methods i.e. recording the obligatory manual and mechanical brushing cycles or for adapting the mechanical properties and adhesive strength to the clinically recorded data.

This pilot study includes 2 in vivo and 3 in vitro parts. The in vivo examinations contain 8 visits for participants. For biofilm formation participants omit cleaning dentures for 12 and 36 hours. Biofilm formation occurs between the visits and removal within the visits. Digital planimetry will be performed to measure the biofilm formation and removal. Within 3 in vitro tests, the mechanical properties of the artificial biofilm substitutes will be adjusted and the reliability tested. The artificial biofilm contains chitosan and methylcellulose. The mechanical brushing cycles needed to remove artificial biofilm substitutes, will be measured by a tooth-brushing simulator under standardized conditions. Digital planimetry of artificial biofilm after brushing will be performed.

The collected data will be used for further conceptualization of the main study.

Eligibility criteria: Inclusion Criteria:

* Individuals 18 years of age or older
* Individuals wearing sufficient acrylic resin (PMMA) complete upper or complete upper and lower denture
* healthy oral mucosa
* written informed consent

Exclusion Criteria:

* Individuals who have severe systemic and/or infectious diseases
* Female individuals who are pregnant or breastfeeding
* allergies or hypersensitivity to the used products and/or materials
* smokers
* Individuals with a history of chronic drug abuse or another illness which does not allow the participant to assess the nature and/or possible consequences of the study
* inability to comply with study protocol requirements
* Individuals who have participated in another clinical study less than 4 weeks prior to the baseline examination

Primary outcomes:
measure: dentures brushing cycles 12 h in vivo
timeFrame: 2 days
measure: brushing cycles in vitro
timeFrame: 4 months
Secondary outcomes:
measure: percentage of plaque (POP)
timeFrame: 3 - 12 weeks
measure: dentures brushing cycles 36 h in vivo
timeFrame: 4 days
measure: samples brushing cycles 12 h in vivo
timeFrame: 2 days
measure: samples brushing cycles 36 h in vivo
timeFrame: 4 days
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Prosthetic Dentistry, Carl Gustav Carus Faculty of Medicine, TU Dresden
state: Saxony
Study officials:
affiliation: Department of Prosthetik Dentistry, Faculty of Medicine, TU Dresden
name: Katarzyna Walczak, Dr.med.dent.
role: STUDY_CHAIR
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