Maintaining Oral Health With Bio-products
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo mouth rinse Placebo: Deionized water (serving as negative control) |
Other: Mouth 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.
Other Names:
|
| Active Comparator: Elmex mouth rinse 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) |
Other: Mouth 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.
Other Names:
|
| Active Comparator: Fluoride mouth rinse Fluoride solution similar to many other commercial mouth rinses containing sodium fluoride (NaF at 500 ppm F-) |
Other: Mouth 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.
Other Names:
|
| Experimental: Plant extract A Plant Extract A |
Other: Mouth 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.
Other Names:
|
| Experimental: Plant extract A with fluoride Plant Extract A + Fluoride |
Other: Mouth rinse 5
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.
Other Names:
|
| Experimental: Plant extract B Plant extract B |
Other: Mouth rinse 6
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.
Other Names:
|
| Experimental: Plant extract B with fluoride Plant Extract B + Fluoride |
Other: Mouth rinse 7
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.
Other Names:
|
| Experimental: Plant extract C Plant extract C |
Other: Mouth rinse 8
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.
Other Names:
|
| Experimental: Plant extract C with fluoride Plant Extract C + Fluoride |
Other: Mouth rinse 9
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
- 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)
- 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 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)
- 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)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Univesity of Bern (Klinik für Zahnerhaltung, Präventiv- und Kinderzahnmedizin) | Bern | BE | Switzerland | 3010 |
Sponsors and Collaborators
- University of Bern
Investigators
- Principal Investigator: Thiago S Carvalho, PD Dr, University of Bern
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SNSF-Project-1904