Effect of Sour Cherry Anthocyanins on Healthy Human Saliva

Effect of Sour Cherry Anthocyanins (Cyanidin Components of Sour Cherry) on Human Saliva and Biofilm Formation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05406011

Enrollment

Registered

2022-06-06

Start date

2020-03-16

Completion date

2024-12-31

Last updated

2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTPelleted 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 daytime (between 12:00 and 14:00) of the week.

DIETARY_SUPPLEMENTPelleted 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 daytime (between 12:00 and 14:00) of the week. Procedure: Scaling after a control period without sour cherry chewing gum usage (1 week).

PROCEDUREScaling

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Caries preventive action of sour cherry chewing gum	Through 3 weeks of the study!	The action of sour cherry anthocyanins on human salivary microbiome.
Action of sour cherry chewing gum in caries prevention	During 3 study weeks!	The action of sour cherry anthocyanins on cytokine's level.
Effect of sour cherry chewing gum in caries prevention	Through study completion (3 weeks)!	The action of sour cherry anthocyanins on mRNA (messenger ribonucleic acid) expression.

Secondary

Measure	Time frame	Description
Additional caries preventive action of toothbrush change during sour cherry chewing gum usage	Till 3 weeks of the study!	The effect of toothbrush change on human salivary microbiome.
Additional effect of toothbrush change in caries prevention during sour cherry chewing gum usage	During 3 study weeks!	The effect of toothbrush change on salivary cytokine's level.
Additional action of toothbrush change in caries prevention during sour cherry chewing gum usage	Through study completion (3 weeks)!	The effect of toothbrush change on salivary mRNA expression.

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026