Dental Caries, Dental Erosion
Conditions
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 (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.
Interventions
OTHERMouth rinse 1
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.
OTHERMouth rinse 2
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.
OTHERMouth 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.
OTHERMouth rinse 4
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.
Sponsors
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Mouth rinses will be placed in coded bottles, and the investigator and patients will not know to which group they belong. This is a cross-over study, where all 12 participants will use all 4 rinses.
Intervention model description
Cross-over study, where all participants will use all treatments. The treatment order will be set at random.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enamel mineral loss | 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 | End of the study arm, expected to be after 1 week of using the mouth rinse | Profilometry of dentine specimens (step height in µm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thickness of the salivary pellicle | End of the study arm, expected to be after 1 week of using the mouth rinse | Measured using TEM (mineralization measured in Delta Z) |
| pH of the participants' biofilm | 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) |
| Identification of which proteins are present in the participants' saliva | 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) |
| How many bacteria are adhered to the biofilm | 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) |
| Identification of the bacteria in the biofilm | 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) |
| Identification of which proteins are present in the participants' salivary pellicle | 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) |
Countries
Switzerland
Outcome results
None listed