Effect of Sour Cherry Anthocyanins on Healthy Human Saliva
- Conditions
- Dental Caries
- Interventions
- Dietary Supplement: Pelleted sour cherry (anthocyanin) containing chewing gum usage.Dietary Supplement: Pelleted chewing gum for stimulated saliva sampling.Procedure: Scaling
- Registration Number
- NCT05406011
- Lead Sponsor
- University of Debrecen
- 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.
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 20
- persons over than 18 years of age with a maximum age of 45 years,
- written informed consent,
- healthy dentition
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Age groups Pelleted chewing gum for stimulated saliva sampling. Participants grouped by their age (Age group I: patients aged between 18-30, age group II: patients aged between 31-45). Age groups Pelleted sour cherry (anthocyanin) containing chewing gum usage. Participants grouped by their age (Age group I: patients aged between 18-30, age group II: patients aged between 31-45). Experimental period Pelleted chewing gum for stimulated saliva sampling. 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. Age groups Scaling Participants grouped by their age (Age group I: patients aged between 18-30, age group II: patients aged between 31-45). Groups by toothbrush change Pelleted sour cherry (anthocyanin) containing chewing gum usage. Half of the group change the toothbrush after scaling and the other half not. Experimental period Pelleted sour cherry (anthocyanin) containing chewing gum usage. 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. Groups by toothbrush change Pelleted chewing gum for stimulated saliva sampling. Half of the group change the toothbrush after scaling and the other half not. Groups by toothbrush change Scaling Half of the group change the toothbrush after scaling and the other half not. Experimental period Scaling 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.
- Primary Outcome Measures
Name Time Method Action of sour cherry chewing gum in caries prevention "During 3 study weeks!" The action of sour cherry anthocyanins on cytokine's level.
Caries preventive action of sour cherry chewing gum "Through 3 weeks of the study!" The action of sour cherry anthocyanins on human salivary microbiome.
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 Outcome Measures
Name Time Method 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.
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 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.
Trial Locations
- Locations (1)
University of Debrecen
🇭🇺Debrecen, Hungary