Univesity of Bern (Klinik für Zahnerhaltung, Präventiv- und Kinderzahnmedizin)
Bern, Canton of Bern, 3010, Switzerland
NCT Number: NCT04033263
This study will follow a randomised, double-blind, cross-over design. Participants will use mouth rinses containing plant extracts and/or fluoride, as well as a mouth rinse containing only water (placebo). They will use oral appliances containing sterilized enamel and dentine slabs, which will be later collected for analyses.
The cross-over design will allow participants to use all rinses, allowing for a comparison between the rinses within each individual.
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Bern, Canton of Bern, 3010, Switzerland
This study will be made in three in situ parts. Participants will wear an oral appliance containing sterilized enamel and dentine slabs. During this experimental phase, they will use the designated mouth rinse. After this period, the investigators will remove the enamel and dentine slabs, and will also collect salivary pellicle and any bacterial biofilm forming on the participant's teeth. Participants will also donate saliva for proteomic analysis (protein profile) to verify if there are any differences in proteins in saliva to proteins in the pellicle. Throughout the whole study, all participants will use standardized oral hygiene products.
The experimental mouth rinses contain plant extracts that could interact with salivary proteins and influence the salivary pellicle and oral biofilm, thus bringing positive results against tooth (enamel and dentine) demineralisation.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will use 10mL of the respective mouth rinse, swish in the mouth for 30 seconds and spit it out. This will be made twice a day, for a total of 5 days.
Other names: Water
Participants will use 10mL of the respective mouth rinse, swish in the mouth for 30 seconds and spit it out. This will be made twice a day, for a total of 5 days.
Other names: Elmex Erosion Protection mouth rinse
Participants will use 10mL of the respective mouth rinse, swish in the mouth for 30 seconds and spit it out. This will be made twice a day, for a total of 5 days.
Other names: Fluoride mouth rinse
Participants will use 10mL of the respective mouth rinse, swish in the mouth for 30 seconds and spit it out. This will be made twice a day, for a total of 5 days.
Other names: Plant extract A and fluoride
Time frame: End of the study arm, expected to be after 1 week of using the mouth rinse
Hardness of enamel slabs (Knoop hardness)
Time frame: End of the study arm, expected to be after 1 week of using the mouth rinse
Profilometry of dentine specimens (step height in µm)
Time frame: End of the study arm, expected to be after 1 week of using the mouth rinse
Proteomic analyses of the saliva (list of proteins present)
Time frame: End of the study arm, expected to be after 1 week of using the mouth rinse
Proteomic analyses of the salivary pellicle (list of proteins present)
Time frame: End of the study arm, expected to be after 1 week of using the mouth rinse
Measured using TEM (mineralization measured in Delta Z)
Time frame: End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
Measured in vivo after using the mouth rinses (pH)
Time frame: End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
Measured after collecting the biofilm (list of bacterial species)
Time frame: End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
Measured after collecting the biofilm (bacteria quantity)
University of Bern
Other
Maintaining Oral Health With Bio-products: a Randomized, Cross-over, in Situ Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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