Maintaining Oral Health With Bio-products

March 10, 2022 updated by: University of Bern

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • BE
      • Bern, BE, Switzerland, 3010
        • Univesity of Bern (Klinik für Zahnerhaltung, Präventiv- und Kinderzahnmedizin)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo mouth rinse
Placebo: Deionized water (serving as negative control)
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.
Other Names:
  • Water
Active Comparator: 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)
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.
Other Names:
  • Elmex Erosion Protection mouth rinse
Active Comparator: Fluoride mouth rinse
Fluoride solution similar to many other commercial mouth rinses containing sodium fluoride (NaF at 500 ppm F-)
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.
Other Names:
  • Fluoride mouth rinse
Experimental: Plant extract A
Plant Extract A
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.
Other Names:
  • Plant extract A
Experimental: Plant extract A with fluoride
Plant Extract A + Fluoride
Other: 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.
Other Names:
  • Plant extract A and fluoride
Experimental: Plant extract B
Other: 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.
Other Names:
  • Plant extract B
Experimental: Plant extract B with fluoride
Plant Extract B + Fluoride
Other: 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.
Other Names:
  • Plant extract B and fluoride
Experimental: Plant extract C
Other: 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.
Other Names:
  • Plant extract C
Experimental: Plant extract C with fluoride
Plant Extract C + Fluoride
Other: 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.
Other Names:
  • Plant extract C and fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enamel mineral loss
Time Frame: End of the study arm, expected to be after 1 week of using the mouth rinse
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
Time Frame: End of the study arm, expected to be after 1 week of using the mouth rinse
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of which proteins are present in the participants' saliva
Time Frame: End of the study arm, expected to be after 1 week of using the mouth rinse
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
Identification of which proteins are present in the participants' salivary pellicle
Time Frame: End of the study arm, expected to be after 1 week of using the mouth rinse
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
Thickness of the salivary pellicle
Time Frame: End of the study arm, expected to be after 1 week of using the mouth rinse
Measured using TEM (mineralization measured in Delta Z)
End of the study arm, expected to be after 1 week of using the mouth rinse
pH of the participants' biofilm
Time Frame: End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
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
Identification of the bacteria in the biofilm
Time Frame: End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
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
How many bacteria are adhered to the biofilm
Time Frame: End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Investigators

  • Principal Investigator: Thiago S Carvalho, PD Dr, University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

September 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (Actual)

July 26, 2019

Study Record Updates

Last Update Posted (Actual)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNSF-Project-1904

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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