An interventional study of Mouth rinse 1 and Mouth rinse 2 in Dental Caries and Dental Erosion, sponsored by University of Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by University of Bern · Not applicable, Interventional, and Prevention
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.
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.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →University of Bern is the lead sponsor of 209 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo: Deionized water (serving as negative control)
Other: Mouth rinse 1
Commercial mouth rinse used as gold standard in erosion studies: elmex® Erosion Protection solution (which contains 800 ppm Sn2+, as SnCl2, and 500 ppm F-, as NaF and AmF)
Other: Mouth rinse 2
Plant Extract A + Fluoride
Other: Mouth rinse 4
NaF Fluoride Rinse
Other: Mouth rinse 3
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.
Also known as: 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.
Also known as: 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.
Also known as: 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.
Also known as: Plant extract A and fluoride
Enamel mineral loss
Hardness of enamel slabs (Knoop hardness)
Time frame: End of the study arm, expected to be after 1 week of using the mouth rinse
Dentine mineral loss
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
Identification of which proteins are present in the participants' saliva
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
Identification of which proteins are present in the participants' salivary pellicle
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
Thickness of the salivary pellicle
Measured using TEM (mineralization measured in Delta Z)
Time frame: End of the study arm, expected to be after 1 week of using the mouth rinse
pH of the participants' biofilm
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
Identification of the bacteria in the biofilm
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
How many bacteria are adhered to the biofilm
Measured after collecting the biofilm (bacteria quantity)
Time frame: End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.