Clinical trial NCT04033263: Maintaining Oral Health With Bio-products
Official title: Maintaining Oral Health With Bio-products: a Randomized, Cross-over, in Situ Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Caries
Dental Erosion
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross-over study, where all participants will use all treatments. The treatment order will be set at random.
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Enamel mineral loss
timeFrame: End of the study arm, expected to be after 1 week of using the mouth rinse
measure: Dentine mineral loss
timeFrame: End of the study arm, expected to be after 1 week of using the mouth rinse
Secondary outcomes:
measure: Identification of which proteins are present in the participants' saliva
timeFrame: End of the study arm, expected to be after 1 week of using the mouth rinse
measure: Identification of which proteins are present in the participants' salivary pellicle
timeFrame: End of the study arm, expected to be after 1 week of using the mouth rinse
measure: Thickness of the salivary pellicle
timeFrame: End of the study arm, expected to be after 1 week of using the mouth rinse
measure: pH of the participants' biofilm
timeFrame: End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
measure: Identification of the bacteria in the biofilm
timeFrame: End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
measure: How many bacteria are adhered to the biofilm
timeFrame: End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Univesity of Bern (Klinik für Zahnerhaltung, Präventiv- und Kinderzahnmedizin)
state: BE
Study officials:
affiliation: University of Bern
name: Thiago S Carvalho, PD Dr
role: PRINCIPAL_INVESTIGATOR
References: