Back to resultsMaintaining Oral Health With Bio-products
Primary Purpose
Dental Caries, Dental Erosion
Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Mouth rinse 1
Mouth rinse 2
Mouth rinse 3
Mouth rinse 4
Mouth rinse 5
Mouth rinse 6
Mouth rinse 7
Mouth rinse 8
Mouth rinse 9
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries
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
Sites / Locations
- Univesity of Bern (Klinik für Zahnerhaltung, Präventiv- und Kinderzahnmedizin)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo mouth rinse
Elmex mouth rinse
Fluoride mouth rinse
Plant extract A
Plant extract A with fluoride
Plant extract B
Plant extract B with fluoride
Plant extract C
Plant extract C with fluoride
Arm Description
Placebo: Deionized water (serving as negative control)
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)
Fluoride solution similar to many other commercial mouth rinses containing sodium fluoride (NaF at 500 ppm F-)
Plant Extract A
Plant Extract A + Fluoride
Plant extract B
Plant Extract B + Fluoride
Plant extract C
Plant Extract C + Fluoride
Outcomes
Primary Outcome Measures
Enamel mineral loss
Hardness of enamel slabs (Knoop hardness)
Dentine mineral loss
Profilometry of dentine specimens (step height in µm)
Secondary Outcome Measures
Identification of which proteins are present in the participants' saliva
Proteomic analyses of the saliva (list of proteins present)
Identification of which proteins are present in the participants' salivary pellicle
Proteomic analyses of the salivary pellicle (list of proteins present)
Thickness of the salivary pellicle
Measured using TEM (mineralization measured in Delta Z)
pH of the participants' biofilm
Measured in vivo after using the mouth rinses (pH)
Identification of the bacteria in the biofilm
Measured after collecting the biofilm (list of bacterial species)
How many bacteria are adhered to the biofilm
Measured after collecting the biofilm (bacteria quantity)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04033263
Brief Title
Maintaining Oral Health With Bio-products
Official Title
Maintaining Oral Health With Bio-products: a Randomized, Cross-over, in Situ Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Dental Erosion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Cross-over study, where all participants will use all treatments. The treatment order will be set at random.
Masking
ParticipantCare Provider
Masking Description
Mouth rinses will be placed in coded bottles, and the investigator and patients will not know to which group they belong.
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo mouth rinse
Arm Type
Placebo Comparator
Arm Description
Placebo: Deionized water (serving as negative control)
Arm Title
Elmex mouth rinse
Arm Type
Active Comparator
Arm 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)
Arm Title
Fluoride mouth rinse
Arm Type
Active Comparator
Arm Description
Fluoride solution similar to many other commercial mouth rinses containing sodium fluoride (NaF at 500 ppm F-)
Arm Title
Plant extract A
Arm Type
Experimental
Arm Description
Plant Extract A
Arm Title
Plant extract A with fluoride
Arm Type
Experimental
Arm Description
Plant Extract A + Fluoride
Arm Title
Plant extract B
Arm Type
Experimental
Arm Description
Plant extract B
Arm Title
Plant extract B with fluoride
Arm Type
Experimental
Arm Description
Plant Extract B + Fluoride
Arm Title
Plant extract C
Arm Type
Experimental
Arm Description
Plant extract C
Arm Title
Plant extract C with fluoride
Arm Type
Experimental
Arm Description
Plant Extract C + Fluoride
Intervention Type
Other
Intervention Name(s)
Mouth rinse 1
Other Intervention Name(s)
Water
Intervention Description
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
Intervention Name(s)
Mouth rinse 2
Other Intervention Name(s)
Elmex Erosion Protection mouth rinse
Intervention Description
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
Intervention Name(s)
Mouth rinse 3
Other Intervention Name(s)
Fluoride mouth rinse
Intervention Description
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
Intervention Name(s)
Mouth rinse 4
Other Intervention Name(s)
Plant extract A
Intervention Description
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
Intervention Name(s)
Mouth rinse 5
Other Intervention Name(s)
Plant extract A and fluoride
Intervention Description
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
Intervention Name(s)
Mouth rinse 6
Other Intervention Name(s)
Plant extract B
Intervention Description
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
Intervention Name(s)
Mouth rinse 7
Other Intervention Name(s)
Plant extract B and fluoride
Intervention Description
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
Intervention Name(s)
Mouth rinse 8
Other Intervention Name(s)
Plant extract C
Intervention Description
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
Intervention Name(s)
Mouth rinse 9
Other Intervention Name(s)
Plant extract C and fluoride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Enamel mineral loss
Description
Hardness of enamel slabs (Knoop hardness)
Time Frame
End of the study arm, expected to be after 1 week of using the mouth rinse
Title
Dentine mineral loss
Description
Profilometry of dentine specimens (step height in µm)
Time Frame
End of the study arm, expected to be after 1 week of using the mouth rinse
Secondary Outcome Measure Information:
Title
Identification of which proteins are present in the participants' saliva
Description
Proteomic analyses of the saliva (list of proteins present)
Time Frame
End of the study arm, expected to be after 1 week of using the mouth rinse
Title
Identification of which proteins are present in the participants' salivary pellicle
Description
Proteomic analyses of the salivary pellicle (list of proteins present)
Time Frame
End of the study arm, expected to be after 1 week of using the mouth rinse
Title
Thickness of the salivary pellicle
Description
Measured using TEM (mineralization measured in Delta Z)
Time Frame
End of the study arm, expected to be after 1 week of using the mouth rinse
Title
pH of the participants' biofilm
Description
Measured in vivo after using the mouth rinses (pH)
Time Frame
End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
Title
Identification of the bacteria in the biofilm
Description
Measured after collecting the biofilm (list of bacterial species)
Time Frame
End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
Title
How many bacteria are adhered to the biofilm
Description
Measured after collecting the biofilm (bacteria quantity)
Time Frame
End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thiago S Carvalho, Priv.-Doz. Dr
Phone
+41 31 632 86 03
Email
thiago.saads@zmk.unibe.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thiago S Carvalho, PD Dr
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univesity of Bern (Klinik für Zahnerhaltung, Präventiv- und Kinderzahnmedizin)
City
Bern
State/Province
BE
ZIP/Postal Code
3010
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thiago S Carvalho, PhD
Email
thiago.saads@zmk.unibe.ch
12. IPD Sharing Statement
Plan to Share IPD
No
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Maintaining Oral Health With Bio-products
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