Maintaining Oral Health With Bio-products (NCT04033263) | Clinical Trial Compass
CompletedNot Applicable
Maintaining Oral Health With Bio-products
Switzerland12 participantsStarted 2024-11-01
Plain-language 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). 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Enamel mineral loss
Timeframe: End of the study arm, expected to be after 1 week of using the mouth rinse
2
Dentine mineral loss
Timeframe: End of the study arm, expected to be after 1 week of using the mouth rinse