NCT04033263

Maintaining Oral Health With Bio-products

Maintaining Oral Health With Bio-products: a Randomized, Cross-over, in Situ Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Bern · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries
• Dental Erosion

Interventions

Type	Name	Description
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	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	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	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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2019-07-26
• Last updated: 2025-09-23

Locations

1 site across 1 country: Switzerland