Maintaining Oral Health With Bio-products

NCT04033263 | Completed

• 1 other identifier: SNSF-Project-1904
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Dental Erosion

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• 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

• 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

• Thickness of the salivary pellicle

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

• pH of the participants' biofilm

  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

  End of the study arm in part 3, expected to be after 1 day of using the mouth rinse

Study Arms (4)

Placebo mouth rinse

PLACEBO COMPARATOR

Placebo: Deionized water (serving as negative control)

Other: Mouth rinse 1

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)

Other: Mouth rinse 2

Plant extract A with fluoride

EXPERIMENTAL

Plant Extract A + Fluoride

Other: Mouth rinse 4

Fluoride

ACTIVE COMPARATOR

NaF Fluoride Rinse

Other: Mouth rinse 3

Interventions

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.

Also known as: Water

Placebo mouth rinse

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.

Also known as: Elmex Erosion Protection mouth rinse

Elmex 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.

Also known as: Fluoride mouth rinse

Fluoride

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.

Also known as: Plant extract A and fluoride

Plant extract A with fluoride

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 concomitant therapy washout requirements prior to and/or during study participation

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

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

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Dental Caries; Tooth Erosion

Interventions

Water; Fluorides

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Hydrofluoric Acid; Fluorine Compounds

Study Officials

• Thiago S Carvalho, PD Dr

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-over study, where all participants will use all treatments. The treatment order will be set at random.

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 26, 2019
• Study Start: November 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)