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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo mouth rinse | Placebo Comparator | Placebo: Deionized water (serving as negative control) |
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| 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) |
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| Plant extract A with fluoride | Experimental | Plant Extract A + Fluoride |
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| Fluoride | Active Comparator | NaF Fluoride Rinse |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mouth rinse 1 | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Enamel mineral loss | Hardness of enamel slabs (Knoop hardness) | 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) | End of the study arm, expected to be after 1 week of using the mouth rinse |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of which proteins are present in the participants' saliva | Proteomic analyses of the saliva (list of proteins present) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thiago S Carvalho, PD Dr | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univesity of Bern (Klinik für Zahnerhaltung, Präventiv- und Kinderzahnmedizin) | Bern | Canton of Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D014077 | Tooth Erosion |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D057085 | Tooth Wear |
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| ID | Term |
|---|---|
| D014867 | Water |
| D005459 | Fluorides |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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Cross-over study, where all participants will use all treatments. The treatment order will be set at random.
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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.
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| Mouth rinse 2 | Other | 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. |
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| Mouth rinse 3 | Other | 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. |
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| Mouth rinse 4 | Other | 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. |
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Proteomic analyses of the salivary pellicle (list of proteins present) |
| 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) | 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) | 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) | 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) | End of the study arm in part 3, expected to be after 1 day of using the mouth rinse |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |