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Completed

NCT Number: NCT04033263

Maintaining Oral Health With Bio-products

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univesity of Bern (Klinik für Zahnerhaltung, Präventiv- und Kinderzahnmedizin)

Bern, Canton of Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Water

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.

Other names: Elmex Erosion Protection mouth rinse

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.

Other names: Fluoride mouth rinse

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.

Other names: Plant extract A and fluoride

Primary outcomes

  1. Enamel mineral loss

    Time frame: End of the study arm, expected to be after 1 week of using the mouth rinse

    Hardness of enamel slabs (Knoop hardness)

  2. Dentine mineral loss

    Time frame: 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 outcomes

  1. Identification of which proteins are present in the participants' saliva

    Time frame: 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)

  2. Identification of which proteins are present in the participants' salivary pellicle

    Time frame: 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)

  3. Thickness of the salivary pellicle

    Time frame: End of the study arm, expected to be after 1 week of using the mouth rinse

    Measured using TEM (mineralization measured in Delta Z)

  4. pH of the participants' biofilm

    Time frame: 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)

  5. Identification of the bacteria in the biofilm

    Time frame: 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)

  6. How many bacteria are adhered to the biofilm

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2019
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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