Effect of Sour Cherry Anthocyanins on Healthy Human Saliva

Sponsor
University of Debrecen (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05406011
Collaborator
(none)
20
1
3
57.5
0.3

Study Details

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 anthocyanine 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Pelleted sour cherry (anthocyanin) containing chewing gum usage.
  • Dietary Supplement: Pelleted chewing gum for stimulated saliva sampling.
  • Procedure: Scaling
N/A

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 anthocyanine containing chewing gum in a study taking a 3-week experimental period. At the beginning of experimental period cariological 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 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 according to the Manufacturer's Instructions. ELISA (Enzyme Linked Immunosorbent Assay) analysis with appropriate saliva analization kit for the listed cytokines as follows: Examined cytokines (PCR and ELISA): Interleukins: IL-1β, IL-2, IL-6; TNF (tumor necrosis factor) alfa, Melatonin (ELISA), Mucin 7 (ELISA) and Mucin 5B (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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Prevention
Official Title:
Effect of Sour Cherry Anthocyanins (Cyanidin Components of Sour Cherry) on Human Saliva and Biofilm Formation
Actual Study Start Date :
Mar 16, 2020
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Age groups

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

Dietary Supplement: Pelleted sour cherry (anthocyanin) containing chewing gum usage.
Dietary Supplement usage (daily 3 times for 2 weeks) with salivary sampling on fixed days (1., 4. and 7.) and daytimes (between 12:00 and 14:00) of the week. Procedure: Scaling after a control period without sour cherry chewing gum usage (1 week).

Dietary Supplement: Pelleted chewing gum for stimulated saliva sampling.
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 daytimes (between 12:00 and 14:00) of the week.

Procedure: Scaling
Scaling after a 1-week control period without chewing the sour cherry gum.

Experimental: Groups by toothbrush change

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

Dietary Supplement: Pelleted sour cherry (anthocyanin) containing chewing gum usage.
Dietary Supplement usage (daily 3 times for 2 weeks) with salivary sampling on fixed days (1., 4. and 7.) and daytimes (between 12:00 and 14:00) of the week. Procedure: Scaling after a control period without sour cherry chewing gum usage (1 week).

Dietary Supplement: Pelleted chewing gum for stimulated saliva sampling.
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 daytimes (between 12:00 and 14:00) of the week.

Procedure: Scaling
Scaling after a 1-week control period without chewing the sour cherry gum.

Experimental: Experimental period

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 cariological 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.

Dietary Supplement: Pelleted sour cherry (anthocyanin) containing chewing gum usage.
Dietary Supplement usage (daily 3 times for 2 weeks) with salivary sampling on fixed days (1., 4. and 7.) and daytimes (between 12:00 and 14:00) of the week. Procedure: Scaling after a control period without sour cherry chewing gum usage (1 week).

Dietary Supplement: Pelleted chewing gum for stimulated saliva sampling.
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 daytimes (between 12:00 and 14:00) of the week.

Procedure: Scaling
Scaling after a 1-week control period without chewing the sour cherry gum.

Outcome Measures

Primary Outcome Measures

  1. Caries preventive action of sour cherry chewing gum ["Through study completion (3 weeks)"]

    The action of sour cherry anthocyanins on human salivary microbiome.

  2. Caries preventive action of sour cherry chewing gum ["Through study completion (3 weeks)"]

    The action of sour cherry anthocyanins on cytokine's level.

  3. Caries preventive action of sour cherry chewing gum ["Through study completion (3 weeks)"]

    The action of sour cherry anthocyanins on mRNA (messenger Ribonucleic Acid) expression.

Secondary Outcome Measures

  1. Additional caries preventive action of toothbrush change during sour cherry chewing gum usage ["Through study completion (3 weeks)"]

    The effect of toothbrush change on human salivary microbiome.

  2. Additional caries preventive action of toothbrush change during sour cherry chewing gum usage ["Through study completion (3 weeks)"]

    The effect of toothbrush change on salivary cytokine's level.

  3. Additional caries preventive action of toothbrush change during sour cherry chewing gum usage ["Through study completion (3 weeks)"]

    The effect of toothbrush change on salivary mRNA expression.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Debrecen Debrecen Hungary 4032

Sponsors and Collaborators

  • University of Debrecen

Investigators

  • Study Director: Judit Remenyik, ass. prof., University of Debrecen, Institute of Food Technology
  • Study Director: Kinga Bágyi, ass. prof., University of Debrecen, Faculty of Dentistry

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Dr. Boglárka Emese Skopkó, Department of Dentoalveolar Surgery, assistant lecturer, University of Debrecen
ClinicalTrials.gov Identifier:
NCT05406011
Other Study ID Numbers:
  • 2022-IV/1120-1/2020
First Posted:
Jun 6, 2022
Last Update Posted:
Jun 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 6, 2022