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Effect of Sour Cherry Anthocyanins on Healthy Human Saliva

U

University of Debrecen

Status

Invitation-only

Conditions

Dental Caries

Treatments

Procedure: Scaling
Dietary Supplement: Pelleted sour cherry (anthocyanin) containing chewing gum usage.
Dietary Supplement: Pelleted chewing gum for stimulated saliva sampling.

Study type

Interventional

Funder types

Other

Identifiers

NCT05406011
2022-IV/1120-1/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 3 patient groups

Age groups
Experimental group
Description:
Participants grouped by their age (Age group I: patients aged between 18-30, age group II: patients aged between 31-45).
Treatment:
Dietary Supplement: Pelleted sour cherry (anthocyanin) containing chewing gum usage.
Dietary Supplement: Pelleted chewing gum for stimulated saliva sampling.
Procedure: Scaling
Groups by toothbrush change
Experimental group
Description:
Half of the group change the toothbrush after scaling and the other half not.
Treatment:
Dietary Supplement: Pelleted sour cherry (anthocyanin) containing chewing gum usage.
Dietary Supplement: Pelleted chewing gum for stimulated saliva sampling.
Procedure: Scaling
Experimental period
Experimental group
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.
Treatment:
Dietary Supplement: Pelleted sour cherry (anthocyanin) containing chewing gum usage.
Dietary Supplement: Pelleted chewing gum for stimulated saliva sampling.
Procedure: Scaling

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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