Status:
COMPLETED
Maintaining Oral Health With Bio-products
Lead Sponsor:
University of Bern
Conditions:
Dental Caries
Dental Erosion
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 (plac...
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 mo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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,
- 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
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04033263
Start Date
November 1 2024
End Date
June 30 2025
Last Update
September 23 2025
Active Locations (1)
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1
Univesity of Bern (Klinik für Zahnerhaltung, Präventiv- und Kinderzahnmedizin)
Bern, Canton of Bern, Switzerland, 3010