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Maintaining Oral Health With Bio-products

NCT ID: NCT04033263

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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

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Dental Caries Dental Erosion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Cross-over study, where all participants will use all treatments. The treatment order will be set at random.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers
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.

Study Groups

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Placebo mouth rinse

Placebo: Deionized water (serving as negative control)

Group Type PLACEBO_COMPARATOR

Mouth rinse 1

Intervention Type 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.

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)

Group Type ACTIVE_COMPARATOR

Mouth rinse 2

Intervention Type 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.

Plant extract A with fluoride

Plant Extract A + Fluoride

Group Type EXPERIMENTAL

Mouth rinse 4

Intervention Type 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.

Fluoride

NaF Fluoride Rinse

Group Type ACTIVE_COMPARATOR

Mouth rinse 3

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Water Elmex Erosion Protection mouth rinse Fluoride mouth rinse Plant extract A and fluoride

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thiago S Carvalho, PD Dr

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

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

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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SNSF-Project-1904

Identifier Type: -

Identifier Source: org_study_id

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