Maintaining Oral Health With Bio-products

University of Bern

Status: Not yet enrolling

Conditions: Dental Caries; Dental Erosion

Treatments: Other: Mouth rinse 2; Other: Mouth rinse 9; Other: Mouth rinse 6; Other: Mouth rinse 3; Other: Mouth rinse 7; Other: Mouth rinse 8; Other: Mouth rinse 1; Other: Mouth rinse 4; Other: Mouth rinse 5

Study type: Interventional

Funder types: Other

Identifiers

NCT04033263

SNSF-Project-1904

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 9 patient groups, including a placebo group

Placebo mouth rinse

Placebo Comparator group

Description:

Placebo: Deionized water (serving as negative control)

Treatment:

Other: Mouth rinse 1

Elmex mouth rinse

Active Comparator group

Description:

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)

Treatment:

Other: Mouth rinse 2

Fluoride mouth rinse

Active Comparator group

Description:

Fluoride solution similar to many other commercial mouth rinses containing sodium fluoride (NaF at 500 ppm F-)

Treatment:

Other: Mouth rinse 3

Plant extract A

Experimental group

Description:

Plant Extract A

Treatment:

Other: Mouth rinse 4

Plant extract A with fluoride

Experimental group

Description:

Plant Extract A + Fluoride

Treatment:

Other: Mouth rinse 5

Plant extract B

Experimental group

Description:

Plant extract B

Treatment:

Other: Mouth rinse 6

Plant extract B with fluoride

Experimental group

Description:

Plant Extract B + Fluoride

Treatment:

Other: Mouth rinse 7

Plant extract C

Experimental group

Description:

Plant extract C

Treatment:

Other: Mouth rinse 8

Plant extract C with fluoride

Experimental group

Description:

Plant Extract C + Fluoride

Treatment:

Other: Mouth rinse 9