Dental CariesNCT05406011
Effect of Sour Cherry Anthocyanins on Healthy Human Saliva
A study testing Pelleted sour cherry (anthocyanin) containing chewing gum usage., Pelleted chewing gum for stimulated saliva sampling. and Scaling in people with Dental Caries, run by University of Debrecen at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Pelleted sour cherry (anthocyanin) containing chewing gum usage., Pelleted chewing gum for stimulated saliva sampling. and Scaling
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHungary
- Study dates
- 16 Mar 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- persons over than 18 years of age with a maximum age of 45 years,
- written informed consent,
- healthy dentition
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sour Cherry Anthocyanins (Cyanidin Components of Sour Cherry) on Human Saliva and Biofilm Formation
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.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- Pelleted sour cherry (anthocyanin) containing chewing gum usage., Pelleted chewing gum for stimulated saliva sampling., Scaling
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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.
ScalingProcedure or surgery
Scaling after a 1-week control period without chewing the sour cherry gum.
| Study group | Role | What they receive |
|---|---|---|
| Age groups | Experimental | Participants grouped by their age (Age group I: patients aged between 18-30, age group II: patients aged between 31-45). Receives: 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. Receives: 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. Receives: Dietary Supplement: Pelleted sour cherry (anthocyanin) containing chewing gum usage.; Dietary Supplement: Pelleted chewing gum for stimulated saliva sampling.; Procedure: Scaling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries preventive action of sour cherry chewing gum
The action of sour cherry anthocyanins on human salivary microbiome.
Measured: "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.
Measured: "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.
Measured: "Through study completion (3 weeks)!"
Secondary outcomes (3)
Additional caries preventive action of toothbrush change during sour cherry chewing gum usage
The effect of toothbrush change on human salivary microbiome.
Measured: "Till 3 weeks of the study!"
Additional effect of toothbrush change in caries prevention during sour cherry chewing gum usage
The effect of toothbrush change on salivary cytokine's level.
Measured: "During 3 study weeks!"
Additional action of toothbrush change in caries prevention during sour cherry chewing gum usage
The effect of toothbrush change on salivary mRNA expression.
Measured: "Through study completion (3 weeks)!"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start16 Mar 2020
- Primary completion1 Aug 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Debrecen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Boglárka Emese Skopkó, University of Debrecen
- Investigators
- Judit Remenyik, ass. prof., Study director, University of Debrecen, Institute of Food TechnologyKinga Bágyi, ass. prof., Study director, University of Debrecen, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406011
- Sponsor's protocol ID
- 2022-IV/1120-1/2020
- Status last verified
- May 2023
- First submitted
- 11 Mar 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29978173Homoki 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.
PubMed 26471548
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sour Cherry Anthocyanins (Cyanidin Components of Sour Cherry) on Human Saliva and Biofilm Formation
- ClinicalTrials.gov ID
- NCT05406011
- Acronym / sponsor ID
- 2022-IV/1120-1/2020
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of DebrecenUniversity, hospital or other
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Age groups | Experimental | Dietary Supplement: Pelleted sour cherry (anthocyanin) containing chewing gum usage., Dietary Supplement: Pelleted chewing gum for stimulated saliva sampling., Procedure: ScalingParticipants grouped by their age (Age group I: patients aged between 18-30, age group II: patients aged between 31-45). |
| Groups by toothbrush change | Experimental | Dietary Supplement: Pelleted sour cherry (anthocyanin) containing chewing gum usage., Dietary Supplement: Pelleted chewing gum for stimulated saliva sampling., Procedure: ScalingHalf of the group change the toothbrush after scaling and the other half not. |
| Experimental period | Experimental | Dietary Supplement: Pelleted sour cherry (anthocyanin) containing chewing gum usage., Dietary Supplement: Pelleted chewing gum for stimulated saliva sampling., Procedure: ScalingControl: 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- persons over than 18 years of age with a maximum age of 45 years,
- written informed consent,
- healthy dentition
Key exclusion criteria (6 listed)
- smoking,
- infectious disease treated with antibiotic in the last two months,
- xerostomia,
- acute oral lesion,
- allergy (lactose),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 daytime (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 | Age groups, Experimental period, Groups by toothbrush change |
| 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 daytime (between 12:00 and 14:00) of the week. | Dietary supplement | Age groups, Experimental period, Groups by toothbrush change |
| ScalingScaling after a 1-week control period without chewing the sour cherry gum. | Procedure or surgery | Age groups, Experimental period, Groups by toothbrush change |
Primary outcome
Caries preventive action of sour cherry chewing gum
Time frame: "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
Time frame: "During 3 study weeks!"
The action of sour cherry anthocyanins on cytokine's level.
Effect of sour cherry chewing gum in caries prevention
Time frame: "Through study completion (3 weeks)!"
The action of sour cherry anthocyanins on mRNA (messenger ribonucleic acid) expression.
3 secondary outcomes
Additional caries preventive action of toothbrush change during sour cherry chewing gum usage
Time frame: "Till 3 weeks of the study!"
Additional effect of toothbrush change in caries prevention during sour cherry chewing gum usage
Time frame: "During 3 study weeks!"
Additional action of toothbrush change in caries prevention during sour cherry chewing gum usage
Time frame: "Through study completion (3 weeks)!"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Background: PubMed 29978173Homoki 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.
- Background: PubMed 26471548Homoki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judit Remenyik, ass. prof. study director
University of Debrecen, Institute of Food Technology
Kinga Bágyi, ass. prof. study director
University of Debrecen, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelleted sour cherry (anthocyanin) containing chewing gum usage., Pelleted chewing gum for stimulated saliva sampling. and Scaling in people with Dental Caries, run by University of Debrecen at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries preventive action of sour cherry chewing gum (time frame: "Through 3 weeks of the study!"). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05406011, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.