BiofilmKÜBINCT04247438
Dentures Biofilm and Artificial Biofilm Substitute
A study testing 12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it. in people with Biofilm, run by Technische Universität Dresden at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biofilm
- What is being tested?
- 12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- 2 Mar 2020to 31 Dec 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Prosthetic Dentistry, Carl Gustav Carus Faculty of Medicine, TU Dresden
Dresden, Saxony, 01307
About this study
Official title: Polysaccharide-based, Artificial Biofilm Substitute - Clinical Pilot Study for Validation Process
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.
Read the 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.
- Conditions
- Biofilm
- Being tested
- 12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it.
- Keywords
- dental biofilm, dental plaque, polysaccharides, chitosan, methylcellulose, denture biofilm, denture plaque, biofilm model
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Biofilm formation | Other | Biofilm formation after 12 and 36 h on PMMA (polymethyl methacrylate) dentures and the number of brushing cycles needed to remove it. Receives: Other: 12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it. |
What is being measured
The primary outcome is the main question the study is designed to answer.
dentures brushing cycles 12 h in vivo
Capturing the data for the number of brushing cycles needed to remove artificial biofilm from dentures worn by participants for 12h.
Measured: 2 days
brushing cycles in vitro
Capturing the data for the number of brushing cycles needed to remove artificial biofilm from dentures or samples.
Measured: 4 months
Secondary outcomes (4)
percentage of plaque (POP)
Measuring of denture area covered with biofilm by digital planimetry.
Measured: 3 - 12 weeks
dentures brushing cycles 36 h in vivo
Capturing the data for the number of brushing cycles needed to remove artificial biofilm from dentures worn by participants for 36 h.
Measured: 4 days
samples brushing cycles 12 h in vivo
Capturing the data for the number of brushing cycles needed to remove artificial biofilm from samples worn by participants for 12h.
Measured: 2 days
samples brushing cycles 36 h in vivo
Capturing the data for the number of brushing cycles needed to remove artificial biofilm from samples worn by participants for 36 h.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start2 Mar 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for BiofilmStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Katarzyna Walczak, Dr.med.dent., Study chair, Department of Prosthetik Dentistry, Faculty of Medicine, TU Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247438
- Sponsor's protocol ID
- TUDKW20200115
- Other IDs
- 427547277
- Acronym
- KÜBI
- Status last verified
- Dec 2021
- First submitted
- 13 Jan 2020
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bowen WH, Burne RA, Wu H, Koo H. Oral Biofilms: Pathogens, Matrix, and Polymicrobial Interactions in Microenvironments. Trends Microbiol. 2018 Mar;26(3):229-242. doi: 10.1016/j.tim.2017.09.008. Epub 2017 Oct 30.
PubMed 29097091Flemming HC, Wingender J. The biofilm matrix. Nat Rev Microbiol. 2010 Sep;8(9):623-33. doi: 10.1038/nrmicro2415. Epub 2010 Aug 2.
PubMed 20676145Nikawa H, Hamada T, Yamamoto T. Denture plaque--past and recent concerns. J Dent. 1998 May;26(4):299-304. doi: 10.1016/s0300-5712(97)00026-2.
PubMed 9611934Coulthwaite L, Verran J. Potential pathogenic aspects of denture plaque. Br J Biomed Sci. 2007;64(4):180-9. doi: 10.1080/09674845.2007.11732784.
PubMed 18236742Russell SL, Boylan RJ, Kaslick RS, Scannapieco FA, Katz RV. Respiratory pathogen colonization of the dental plaque of institutionalized elders. Spec Care Dentist. 1999 May-Jun;19(3):128-34. doi: 10.1111/j.1754-4505.1999.tb01413.x.
PubMed 10860077El-Solh AA, Pietrantoni C, Bhat A, Okada M, Zambon J, Aquilina A, Berbary E. Colonization of dental plaques: a reservoir of respiratory pathogens for hospital-acquired pneumonia in institutionalized elders. Chest. 2004 Nov;126(5):1575-82. doi: 10.1378/chest.126.5.1575.
PubMed 15539730Hoad-Reddick G, Grant AA, Griffiths CS. Investigation into the cleanliness of dentures in an elderly population. J Prosthet Dent. 1990 Jul;64(1):48-52. doi: 10.1016/0022-3913(90)90152-3.
PubMed 2384898
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polysaccharide-based, Artificial Biofilm Substitute - Clinical Pilot Study for Validation Process
- ClinicalTrials.gov ID
- NCT04247438
- Acronym / sponsor ID
- KÜBI / TUDKW20200115
- Conditions
- Biofilm
- Keywords
- dental biofilm, dental plaque, polysaccharides, chitosan, methylcellulose, denture biofilm, denture plaque, biofilm model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 30 Jan 2020 (actual)
- 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Biofilm formation | Other | Other: 12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it.Biofilm formation after 12 and 36 h on PMMA (polymethyl methacrylate) dentures and the number of brushing cycles needed to remove it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| 12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it.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. | Other | Biofilm formation |
Primary outcome
dentures brushing cycles 12 h in vivo
Time frame: 2 days
Capturing the data for the number of brushing cycles needed to remove artificial biofilm from dentures worn by participants for 12h.
brushing cycles in vitro
Time frame: 4 months
Capturing the data for the number of brushing cycles needed to remove artificial biofilm from dentures or samples.
4 secondary outcomes
percentage of plaque (POP)
Time frame: 3 - 12 weeks
dentures brushing cycles 36 h in vivo
Time frame: 4 days
samples brushing cycles 12 h in vivo
Time frame: 2 days
samples brushing cycles 36 h in vivo
Time frame: 4 days
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 3 Dec 2021.
- Background: PubMed 29097091Bowen WH, Burne RA, Wu H, Koo H. Oral Biofilms: Pathogens, Matrix, and Polymicrobial Interactions in Microenvironments. Trends Microbiol. 2018 Mar;26(3):229-242. doi: 10.1016/j.tim.2017.09.008. Epub 2017 Oct 30.
- Background: PubMed 20676145Flemming HC, Wingender J. The biofilm matrix. Nat Rev Microbiol. 2010 Sep;8(9):623-33. doi: 10.1038/nrmicro2415. Epub 2010 Aug 2.
- Background: PubMed 9611934Nikawa H, Hamada T, Yamamoto T. Denture plaque--past and recent concerns. J Dent. 1998 May;26(4):299-304. doi: 10.1016/s0300-5712(97)00026-2.
- Background: PubMed 18236742Coulthwaite L, Verran J. Potential pathogenic aspects of denture plaque. Br J Biomed Sci. 2007;64(4):180-9. doi: 10.1080/09674845.2007.11732784.
- Background: PubMed 10860077Russell SL, Boylan RJ, Kaslick RS, Scannapieco FA, Katz RV. Respiratory pathogen colonization of the dental plaque of institutionalized elders. Spec Care Dentist. 1999 May-Jun;19(3):128-34. doi: 10.1111/j.1754-4505.1999.tb01413.x.
- Background: PubMed 15539730El-Solh AA, Pietrantoni C, Bhat A, Okada M, Zambon J, Aquilina A, Berbary E. Colonization of dental plaques: a reservoir of respiratory pathogens for hospital-acquired pneumonia in institutionalized elders. Chest. 2004 Nov;126(5):1575-82. doi: 10.1378/chest.126.5.1575.
- Background: PubMed 2384898Hoad-Reddick G, Grant AA, Griffiths CS. Investigation into the cleanliness of dentures in an elderly population. J Prosthet Dent. 1990 Jul;64(1):48-52. doi: 10.1016/0022-3913(90)90152-3.
- Individual participant dataSharing planned: No
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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.
Katarzyna Walczak, Dr.med.dent. study chair
Department of Prosthetik Dentistry, Faculty of Medicine, TU Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it. in people with Biofilm, run by Technische Universität Dresden at 1 site in Germany.
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 7 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 3 Dec 2021. 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 Germany. 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?
dentures brushing cycles 12 h in vivo (time frame: 2 days). The study lists 2 primary outcomes in all. 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 NCT04247438, which also lists 7 linked publications.
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 3 Dec 2021.