Dental CariesNCT04033263
Maintaining Oral Health With Bio-products
A study testing Mouth rinse 1, Mouth rinse 2 and Mouth rinse 3 in people with Dental Caries and Dental Erosion, run by University of Bern at 1 site in Switzerland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dental Erosion
- What is being tested?
- Mouth rinse 1, Mouth rinse 2 and Mouth rinse 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2024to 30 Jun 2025
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants will be healthy young adults of both sexes, with normal salivary flow, with no cavitated caries lesions, no gingivitis or periodontal disease, no severe erosive tooth wear, and no other serious general or oral conditions.
- Participants will have signed an informed consent form.
Who cannot join
- Presenting oral diseases or conditions, such as untreated cavitated caries lesions, gingivitis or periodontitis, severe erosive tooth wear, etc.
- Participants who are under orthodontic treatment (wearing braces),
- Contraindications to the mouth rinses under study, e.g. known hypersensitivity or allergy to the investigational product,
- Participants using drugs that cause hyposalivation,
- Women who are pregnant or breast feeding,
- Intention to become pregnant during the course of the study,
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- Individuals suffering from clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons,
- Specific exclusions for the disease under study,
- Specific concomitant therapy washout requirements prior to and/or during study participation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Univesity of Bern (Klinik für Zahnerhaltung, Präventiv- und Kinderzahnmedizin)
Bern, Canton of Bern, 3010
About this study
Official title: Maintaining Oral Health With Bio-products: a Randomized, Cross-over, in Situ Study
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.
Read the detailed description
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.
- Conditions
- Dental Caries, Dental Erosion
- Being tested
- Mouth rinse 1, Mouth rinse 2, Mouth rinse 3, Mouth rinse 4
- Medical subject headings
- Dental Caries, Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouth rinse 1Other
Also called 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.
Mouth rinse 2Other
Also called 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.
Mouth rinse 3Other
Also called 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.
Mouth rinse 4Other
Also called Plant extract A and fluoride
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo mouth rinse | Placebo comparator | Placebo: Deionized water (serving as negative control) Receives: Other: Mouth rinse 1 |
| Elmex mouth rinse | Active comparator | 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) Receives: Other: Mouth rinse 2 |
| Plant extract A with fluoride | Experimental | Plant Extract A + Fluoride Receives: Other: Mouth rinse 4 |
| Fluoride | Active comparator | NaF Fluoride Rinse Receives: Other: Mouth rinse 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enamel mineral loss
Hardness of enamel slabs (Knoop hardness)
Measured: 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)
Measured: End of the study arm, expected to be after 1 week of using the mouth rinse
Secondary outcomes (6)
Identification of which proteins are present in the participants' saliva
Proteomic analyses of the saliva (list of proteins present)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Nov 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of BernThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross-over study, where all participants will use all treatments. The treatment order will be set at random.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thiago S Carvalho, PD Dr, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033263
- Sponsor's protocol ID
- SNSF-Project-1904
- Status last verified
- Sep 2025
- First submitted
- 17 Jul 2019
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berto LP, Ding J, Sakae LO, Niemeyer SH, Wierichs RJ, Ricomini-Filho AP, Meyer-Lueckel H, Baumann T, Carvalho TS. Effect of a sodium fluoride rinse on the composition of early oral biofilms formed in situ on enamel and dentine. Clin Oral Investig. 2026 Sep 4;30(9):430. doi: 10.1007/s00784-026-07121-1.
PubMed 42693341
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Oral Health With Bio-products: a Randomized, Cross-over, in Situ Study
- ClinicalTrials.gov ID
- NCT04033263
- Acronym / sponsor ID
- SNSF-Project-1904
- Conditions
- Dental Caries, Dental Erosion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 26 Jul 2019 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Cross-over study, where all participants will use all treatments. The treatment order will be set at random.
| Arm | Type | Receives |
|---|---|---|
| Placebo mouth rinse | Placebo comparator | Other: Mouth rinse 1Placebo: Deionized water (serving as negative control) |
| Elmex mouth rinse | Active comparator | Other: Mouth rinse 2Commercial 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) |
| Plant extract A with fluoride | Experimental | Other: Mouth rinse 4Plant Extract A + Fluoride |
| Fluoride | Active comparator | Other: Mouth rinse 3NaF Fluoride Rinse |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants will be healthy young adults of both sexes, with normal salivary flow, with no cavitated caries lesions, no gingivitis or periodontal disease, no severe erosive tooth wear, and no other serious general or oral conditions.
- Participants will have signed an informed consent form.
Key exclusion criteria (12 listed)
- Presenting oral diseases or conditions, such as untreated cavitated caries lesions, gingivitis or periodontitis, severe erosive tooth wear, etc.
- Participants who are under orthodontic treatment (wearing braces),
- Contraindications to the mouth rinses under study, e.g. known hypersensitivity or allergy to the investigational product,
- Participants using drugs that cause hyposalivation,
- Women who are pregnant or breast feeding,
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 |
|---|---|---|
| Mouth rinse 1Also: WaterParticipants 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 | Placebo mouth rinse |
| Mouth rinse 2Also: Elmex Erosion Protection mouth rinseParticipants 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 | Elmex mouth rinse |
| Mouth rinse 3Also: Fluoride mouth rinseParticipants 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 | Fluoride |
| Mouth rinse 4Also: Plant extract A and fluorideParticipants 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 | Plant extract A with fluoride |
Primary outcome
Enamel mineral loss
Time frame: End of the study arm, expected to be after 1 week of using the mouth rinse
Hardness of enamel slabs (Knoop hardness)
Dentine mineral loss
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)
6 secondary outcomes
Identification of which proteins are present in the participants' saliva
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
Time frame: End of the study arm, expected to be after 1 week of using the mouth rinse
Thickness of the salivary pellicle
Time frame: End of the study arm, expected to be after 1 week of using the mouth rinse
pH of the participants' biofilm
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
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
Time frame: End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
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 23 Sep 2025.
- Derived from this study: PubMed 42693341Berto LP, Ding J, Sakae LO, Niemeyer SH, Wierichs RJ, Ricomini-Filho AP, Meyer-Lueckel H, Baumann T, Carvalho TS. Effect of a sodium fluoride rinse on the composition of early oral biofilms formed in situ on enamel and dentine. Clin Oral Investig. 2026 Sep 4;30(9):430. doi: 10.1007/s00784-026-07121-1.
- 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.
Thiago S Carvalho, PD Dr principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouth rinse 1, Mouth rinse 2 and Mouth rinse 3 in people with Dental Caries and Dental Erosion, run by University of Bern at 1 site in Switzerland.
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 2 inclusion and 12 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 23 Sep 2025. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Enamel mineral loss (time frame: End of the study arm, expected to be after 1 week of using the mouth rinse). 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 NCT04033263, which also lists 1 linked publication.
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 23 Sep 2025.