Effect of Sour Cherry Anthocyanins on Healthy Human Saliva

NCT05406011 | Unknown DMC

• 1 other identifier: 2022-IV/1120-1/2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (3)

• Caries preventive action of sour cherry chewing gum

  The action of sour cherry anthocyanins on human salivary microbiome.

  "Through 3 weeks of the study!"

• Action of sour cherry chewing gum in caries prevention

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

  "During 3 study weeks!"

• Effect of sour cherry chewing gum in caries prevention

  The action of sour cherry anthocyanins on mRNA (messenger ribonucleic acid) expression.

  "Through study completion (3 weeks)!"

Secondary Outcomes (3)

• Additional caries preventive action of toothbrush change during sour cherry chewing gum usage

  "Till 3 weeks of the study!"

• Additional effect of toothbrush change in caries prevention during sour cherry chewing gum usage

  "During 3 study weeks!"

• Additional action of toothbrush change in caries prevention during sour cherry chewing gum usage

  "Through study completion (3 weeks)!"

Study Arms (3)

Age groups

EXPERIMENTAL

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: Pelleted chewing gum for stimulated saliva sampling.; Procedure: Scaling

Groups by toothbrush change

EXPERIMENTAL

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: Pelleted chewing gum for stimulated saliva sampling.; Procedure: Scaling

Experimental period

EXPERIMENTAL

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.

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

Interventions

Pelleted sour cherry (anthocyanin) containing chewing gum usage. DIETARY_SUPPLEMENT

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).

Age groups; Experimental period; Groups by toothbrush change

Pelleted chewing gum for stimulated saliva sampling. DIETARY_SUPPLEMENT

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.

Age groups; Experimental period; Groups by toothbrush change

Scaling PROCEDURE

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

Age groups; Experimental period; Groups by toothbrush change

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• persons over than 18 years of age with a maximum age of 45 years,
• written informed consent,
• healthy dentition

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Debrecen: lead

Study Sites (1)

University of Debrecen

Debrecen, 4032, Hungary

Location

Related Publications (2)

• 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.

  PMID: 29978173 BACKGROUND

• 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.

  PMID: 26471548 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Anthocyanins; Tooth Exfoliation

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates; Pigments, Biological; Biological Factors; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Judit Remenyik, ass. prof.

  University of Debrecen, Institute of Food Technology

  STUDY DIRECTOR

• Kinga Bágyi, ass. prof.

  University of Debrecen, Faculty of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Dentoalveolar Surgery, assistant lecturer

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: June 6, 2022
• Study Start: March 16, 2020
• Primary Completion: August 1, 2023
• Study Completion: December 31, 2024
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)