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Effect of Sour Cherry Anthocyanins on Healthy Human Saliva

Primary Purpose

Dental Caries

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Pelleted sour cherry (anthocyanin) containing chewing gum usage.
Pelleted chewing gum for stimulated saliva sampling.
Scaling
Sponsored by
University of Debrecen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • persons over than 18 years of age,
  • written informed consent,
  • healthy dentition

Exclusion Criteria:

  • smoking,
  • infectious disease treated with antibiotic in the last two months,
  • xerostomia,
  • acute oral lesion,
  • allergy (lactose),
  • systemic or mental condition which remorate the participation.

Sites / Locations

  • University of Debrecen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Age groups

Groups by toothbrush change

Experimental period

Arm Description

Participants grouped by their age (Age group I: patients aged between 18-30, age group II: patients aged between 31-45).

Half of the group change the toothbrush after scaling and the other half not.

Control: Control period without sour cherry chewing gum usage, with saliva sampling on fixed appointments (between 12:00 and 14:00, 0th, 4th and 7th day of the week) of the week. At the beginning oral and basic periodontal examinations performed. Plaque and calculus index at every sampling occasions. Prevention: After a full mouth scaling sour cherry chewing gum usage, for a week. Saliva sampling on the same days. Plaque and calculus index at every sampling occasions. Therapeutic: Sour cherry chewing gum usage, for one more week. Saliva sampling on the same days. Plaque and calculus index at every sampling occasions. Control (without sour cherry chewing gum usage), prevention and therapeutic periods takes 3 weeks together.

Outcomes

Primary Outcome Measures

Caries preventive action of sour cherry chewing gum
The action of sour cherry anthocyanins on human salivary microbiome.
Action of sour cherry chewing gum in caries prevention
The action of sour cherry anthocyanins on cytokine's level.
Effect of sour cherry chewing gum in caries prevention
The action of sour cherry anthocyanins on mRNA (messenger ribonucleic acid) expression.

Secondary Outcome Measures

Additional caries preventive action of toothbrush change during sour cherry chewing gum usage
The effect of toothbrush change on human salivary microbiome.
Additional effect of toothbrush change in caries prevention during sour cherry chewing gum usage
The effect of toothbrush change on salivary cytokine's level.
Additional action of toothbrush change in caries prevention during sour cherry chewing gum usage
The effect of toothbrush change on salivary mRNA expression.

Full Information

First Posted
March 11, 2022
Last Updated
May 15, 2023
Sponsor
University of Debrecen
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1. Study Identification

Unique Protocol Identification Number
NCT05406011
Brief Title
Effect of Sour Cherry Anthocyanins on Healthy Human Saliva
Official Title
Effect of Sour Cherry Anthocyanins (Cyanidin Components of Sour Cherry) on Human Saliva and Biofilm Formation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 16, 2020 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Debrecen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The experiment is based on earlier research where it was proven that chewing gum usage with anthocyanin rich sour cherry extract significantly reduces the amount of human salivary alpha-amylase in unstimulated saliva samples and stimulated saliva samples taken in every 10 minutes till a half an hour as compared to placebo. The S. mutans counts' number on agar base cultures were greater in case of the stimulated samples of placebo and anthocyanin containing chewing gum groups. The investigators' aims were to extend the background of the earlier established phenomena: The sour cherry (anthocyanin) containing chewing gum usage (around 2 weeks, daily 3 times) is beneficent on the human oral microflora and cytokine level/expression.
Detailed Description
The experiment is based on earlier research where it was proven that chewing gum usage with anthocyanin rich sour cherry extract significantly reduces the amount of human salivary alpha-amylase in unstimulated saliva samples and stimulated saliva samples taken in every 5 minutes till a half an hour as compared to placebo. The investigators' study: Examination the effect of sour cherry anthocyanin containing chewing gum in a study taking a 3-week experimental period. At the beginning of experimental period oral and basic periodontal examination of the participants. Selection of healthy young adults (10 person) and adults (10 person), who has good oral hygiene, do not suffer from serious general disease and do not get respiratory infection treated with antibiotics in the past 2 months. Arranging saliva sampling on fixed appointments (between 12:00 and 14:00, 1st, 4th and 7th day of the week) through 3 weeks. On the 1. week, which is a control period taking of resting saliva samples and stimulated saliva samples from the participants. The stimulated saliva sampling is made after chewing of a gum without active ingredient. At the end of the control week a full mouth scaling is made and after it all of the participants get sour cherry containing chewing gums to chew 3x daily till 2 weeks, and the sampling occasions arranged on the same days as on the control week. After scaling 10 participant change their toothbrush, and 10 do not change. The saliva sample analyzation is placed in the Institute of Food Technology, the Department of Human Genetics and Department of Microbiology where they are frozen on -80 Celsius till the laboratory analysis. 16S (16 Svedberg) rRNA (ribosomal ribonucleic acid) sequencing is starting with DNA isolation by Inhibitor Removal Technology followed by sequencing with Illumina MiSeqSystem. PCR (Polymerase Chain Reaction) analysis of saliva samples starting with RNA isolation of samples with MagMAX Viral Kit, followed by RNA transcription and qPCR (quantitative polymerase chain reaction ) according to the Manufacturer's Instructions. ELISA (Enzyme Linked Immunosorbent Assay) analysis with appropriate saliva analyzation kit for the listed cytokines as follows: Examined cytokines (PCR and ELISA): Interleukins: Interleukin-1β, Interleukin-2, Interleukin-6; TNF(tumor necrosis factor) alfa, Melatonin (ELISA) , Mucin 7 (ELISA) and Mucin-5B (5subtypeB) (ELISA). The investigators' aims to are to extend the background of the earlier established phenomena: The sour cherry (anthocyanin) containing chewing gum usage (around 2 weeks, daily 3 times) is beneficent on the human oral microflora and cytokine level/expression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants are subdivided in parallel groups by their age and according to the toothbrush change (to change or not to change the toothbrush) after scaling.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Age groups
Arm Type
Experimental
Arm Description
Participants grouped by their age (Age group I: patients aged between 18-30, age group II: patients aged between 31-45).
Arm Title
Groups by toothbrush change
Arm Type
Experimental
Arm Description
Half of the group change the toothbrush after scaling and the other half not.
Arm Title
Experimental period
Arm Type
Experimental
Arm Description
Control: Control period without sour cherry chewing gum usage, with saliva sampling on fixed appointments (between 12:00 and 14:00, 0th, 4th and 7th day of the week) of the week. At the beginning oral and basic periodontal examinations performed. Plaque and calculus index at every sampling occasions. Prevention: After a full mouth scaling sour cherry chewing gum usage, for a week. Saliva sampling on the same days. Plaque and calculus index at every sampling occasions. Therapeutic: Sour cherry chewing gum usage, for one more week. Saliva sampling on the same days. Plaque and calculus index at every sampling occasions. Control (without sour cherry chewing gum usage), prevention and therapeutic periods takes 3 weeks together.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pelleted sour cherry (anthocyanin) containing chewing gum usage.
Intervention Description
Dietary Supplement usage (daily 3 times for 2 weeks) with salivary sampling on fixed days (1., 4. and 7.) and daytime (between 12:00 and 14:00) of the week. Procedure: Scaling after a control period without sour cherry chewing gum usage (1 week).
Intervention Type
Dietary Supplement
Intervention Name(s)
Pelleted chewing gum for stimulated saliva sampling.
Intervention Description
Stimulated saliva sampling after chewing a pelleted gum without active ingredient (used only before stimulated saliva sampling), during the whole experimental period (control and parallel with sour cherry chewing gum usage) with sampling on fixed days (1., 4. and 7.) and daytime (between 12:00 and 14:00) of the week.
Intervention Type
Procedure
Intervention Name(s)
Scaling
Intervention Description
Scaling after a 1-week control period without chewing the sour cherry gum.
Primary Outcome Measure Information:
Title
Caries preventive action of sour cherry chewing gum
Description
The action of sour cherry anthocyanins on human salivary microbiome.
Time Frame
"Through 3 weeks of the study!"
Title
Action of sour cherry chewing gum in caries prevention
Description
The action of sour cherry anthocyanins on cytokine's level.
Time Frame
"During 3 study weeks!"
Title
Effect of sour cherry chewing gum in caries prevention
Description
The action of sour cherry anthocyanins on mRNA (messenger ribonucleic acid) expression.
Time Frame
"Through study completion (3 weeks)!"
Secondary Outcome Measure Information:
Title
Additional caries preventive action of toothbrush change during sour cherry chewing gum usage
Description
The effect of toothbrush change on human salivary microbiome.
Time Frame
"Till 3 weeks of the study!"
Title
Additional effect of toothbrush change in caries prevention during sour cherry chewing gum usage
Description
The effect of toothbrush change on salivary cytokine's level.
Time Frame
"During 3 study weeks!"
Title
Additional action of toothbrush change in caries prevention during sour cherry chewing gum usage
Description
The effect of toothbrush change on salivary mRNA expression.
Time Frame
"Through study completion (3 weeks)!"

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: persons over than 18 years of age with a maximum age of 45 years, written informed consent, healthy dentition Exclusion Criteria: smoking, infectious disease treated with antibiotic in the last two months, xerostomia, acute oral lesion, allergy (lactose), systemic or mental condition which contraindicate the participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judit Remenyik, ass. prof.
Organizational Affiliation
University of Debrecen, Institute of Food Technology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kinga Bágyi, ass. prof.
Organizational Affiliation
University of Debrecen, Faculty of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
University of Debrecen
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29978173
Citation
Homoki J , Gyemant G , Balogh P , Stundl L , Biro-Molnar P , Paholcsek M , Varadi J , Ferenc F , Kelentey B , Nemes J , Remenyik J . Sour cherry extract inhibits human salivary alpha-amylase and growth of Streptococcus mutans (a pilot clinical study). Food Funct. 2018 Jul 17;9(7):4008-4016. doi: 10.1039/c8fo00064f.
Results Reference
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PubMed Identifier
26471548
Citation
Homoki JR, Nemes A, Fazekas E, Gyemant G, Balogh P, Gal F, Al-Asri J, Mortier J, Wolber G, Babinszky L, Remenyik J. Anthocyanin composition, antioxidant efficiency, and alpha-amylase inhibitor activity of different Hungarian sour cherry varieties (Prunus cerasus L.). Food Chem. 2016 Mar 1;194:222-9. doi: 10.1016/j.foodchem.2015.07.130. Epub 2015 Jul 29.
Results Reference
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Effect of Sour Cherry Anthocyanins on Healthy Human Saliva

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