Maintaining Oral Health With Bio-products

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04033263
• Other study ID #: SNSF-Project-1904
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: University of Bern
• Contact: Thiago S Carvalho, Priv.-Doz. Dr
• Phone: +41 31 632 86 03
• Email: thiago.saads[@]zmk.unibe.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Erosion
• Tooth Erosion

Intervention

Other:
• 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.
• 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.
• 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.
• 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.
• Mouth rinse 5
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.
• Mouth rinse 6
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.
• Mouth rinse 7
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.
• Mouth rinse 8
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.
• Mouth rinse 9
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.

Locations

Country	Name	City	State
Switzerland	Univesity of Bern (Klinik für Zahnerhaltung, Präventiv- und Kinderzahnmedizin)	Bern	BE

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Identification of which proteins are present in the participants' saliva	Proteomic analyses of the saliva (list of proteins present)	End of the study arm, expected to be after 1 week of using the mouth rinse
Secondary	Identification of which proteins are present in the participants' salivary pellicle	Proteomic analyses of the salivary pellicle (list of proteins present)	End of the study arm, expected to be after 1 week of using the mouth rinse
Secondary	Thickness of the salivary pellicle	Measured using TEM (mineralization measured in Delta Z)	End of the study arm, expected to be after 1 week of using the mouth rinse
Secondary	pH of the participants' biofilm	Measured in vivo after using the mouth rinses (pH)	End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
Secondary	Identification of the bacteria in the biofilm	Measured after collecting the biofilm (list of bacterial species)	End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
Secondary	How many bacteria are adhered to the biofilm	Measured after collecting the biofilm (bacteria quantity)	End of the study arm in part 3, expected to be after 1 day of using the mouth rinse