Maintaining Oral Health With Bio-products

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

Sponsors

Lead Sponsor: University of Bern

Source University of Bern
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.

Overall Status Not yet recruiting
Start Date November 2020
Completion Date December 2023
Primary Completion Date September 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Enamel mineral loss End of the study arm, expected to be after 1 week of using the mouth rinse
Dentine mineral loss End of the study arm, expected to be after 1 week of using the mouth rinse
Secondary Outcome
Measure Time Frame
Identification of which proteins are present in the participants' saliva and pellicle End of the study arm, expected to be after 1 week of using the mouth rinse
Thickness of the salivary pellicle End of the study arm, expected to be after 1 week of using the mouth rinse
pH of the participants' biofilm 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 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 End of the study arm in part 3, expected to be after 1 day of using the mouth rinse
Enrollment 45
Condition
Intervention

Intervention Type: Other

Intervention Name: Mouth rinse 1

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.

Arm Group Label: Placebo mouth rinse

Other Name: Water

Intervention Type: Other

Intervention Name: Mouth rinse 2

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.

Arm Group Label: Elmex mouth rinse

Other Name: Elmex Erosion Protection mouth rinse

Intervention Type: Other

Intervention Name: Mouth rinse 3

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.

Arm Group Label: Fluoride mouth rinse

Other Name: Fluoride mouth rinse

Intervention Type: Other

Intervention Name: Mouth rinse 4

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.

Arm Group Label: Plant extract A

Other Name: Plant extract A

Intervention Type: Other

Intervention Name: Mouth rinse 5

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.

Arm Group Label: Plant extract A with fluoride

Other Name: Plant extract A and fluoride

Intervention Type: Other

Intervention Name: Mouth rinse 6

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.

Arm Group Label: Plant extract B

Other Name: Plant extract B

Intervention Type: Other

Intervention Name: Mouth rinse 7

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.

Arm Group Label: Plant extract B with fluoride

Other Name: Plant extract B and fluoride

Intervention Type: Other

Intervention Name: Mouth rinse 8

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.

Arm Group Label: Plant extract C

Other Name: Plant extract C

Intervention Type: Other

Intervention Name: Mouth rinse 9

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.

Arm Group Label: Plant extract C with fluoride

Other Name: Plant extract C and fluoride

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Thiago S Carvalho, PD Dr Principal Investigator University of Bern
Overall Contact

Last Name: Thiago S Carvalho, Priv.-Doz. Dr

Phone: +41 31 632 86 03

Email: [email protected]

Verification Date

July 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 9
Arm Group

Label: Placebo mouth rinse

Type: Placebo Comparator

Description: Placebo: Deionized water (serving as negative control)

Label: Elmex mouth rinse

Type: Active Comparator

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)

Label: Fluoride mouth rinse

Type: Active Comparator

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

Label: Plant extract A

Type: Experimental

Description: Plant Extract A

Label: Plant extract A with fluoride

Type: Experimental

Description: Plant Extract A + Fluoride

Label: Plant extract B

Type: Experimental

Description: Plant Extract B

Label: Plant extract B with fluoride

Type: Experimental

Description: Plant Extract B + Fluoride

Label: Plant extract C

Type: Experimental

Description: Plant Extract C

Label: Plant extract C with fluoride

Type: Experimental

Description: Plant Extract C + Fluoride

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Intervention Model Description: Total of 9 arms initially, and later the study will concentrate on 5 amrs

Primary Purpose: Prevention

Masking: Double (Participant, Care Provider)

Masking Description: Mouth rinses will be placed in coded bottles, and the investigator and patients will not know to which group they belong.

Source: ClinicalTrials.gov