The Effect of Oral Sprays on Salivary pH Changes After Coca-cola Consumption
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- The time required for salivary pH recovery after Coca-Cola consumption
研究概览
简要总结
The aim of the study is to assess the effect of oral foams on salivary pH changes after Coca-cola consumption in young adults.
详细描述
This will be a cross-over clinical trial assessing the effect of oral foams containing zink hydroxiapatite and probiotics (Lactobacillus, Bifidobacterium), Olaflur (amino fluoride), and oral spray with alkaline thermal water. The study will be conducted in six visits over a period of 1.5 months. After enrolment, dental examination will be performed using the following indices: DMFT, OHI-S index, Bleeding index. Saliva buffer capacity, salivary flow rate, and baseline salivary pH will be measured. Salivary pH changes will be registered after consumption of Coca-cola alone or followed by each of the tested products application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females and males
- •Aged between 18-44 years
- •Willingness to comply with all study procedures and availability for the duration of the study.
- •Subjects who signed informed consent
排除标准
- •History of chemotherapy or radiotherapy;
- •An oral mucosa pathology;
- •Orthodontic treatment within the previous 3 months;
- •Dental bleaching within the previous 3 months;
- •Withdrawal of consent;
- •Patient refusal to continue participation in the study;
- •Detection of an allergic reaction to any components of the dental foams or carbonated drinks used in the study.
研究组 & 干预措施
No intervention (negative control)
Negative control
干预措施: No intervention (negative control) (Other)
Water (positive control)
Tap water
干预措施: Water (positive control) (Other)
Dental foam "Biorepair PERIBIOMA"
Ingredients:
Aqua, Sorbitol, Xylitol, Zinc Hydroxyapatite, Aroma, Pistacia Lentiscus (Mastic) Gum Oil, Lactobacillus, Bifidobacterium, Sodium Hyaluronate, Ascorbic Acid, Hamamelis Virginiana Leaf Extract, Spirulina Platensis Extract, Calendula Officinalis Flower Extract, Tocopheryl Acetate, Retinyl Palmitate, Eucalyptus Globulus Leaf Oil, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Sodium Benzoate, Cocamidopropyl Betaine, Glycerin, Maltodextrin, Sodium Saccharin, Helianthus Annuus Seed Oil, Potassium Sorbate, BHT, Limonene, CI 16255.
干预措施: Dental foam "Biorepair PERIBIOMA" (Drug)
Spray "BUCCOTHERM"
Aqua (Castéra-Verduzan Thermal Spring water), Alcohol, Xylitol, Glycerin, Camellia sinensis leaf water, Mentha piperita leaf water, Hydrogenated starch hydrolysate, Aqua, Aroma, Limonene, Benzyl alcohol, Dehydroacetic acid.
干预措施: Dental spray "BUCCOTHERM" (Drug)
结局指标
主要结局
The time required for salivary pH recovery after Coca-Cola consumption
时间窗: 1 hour
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption and further every 5 minutes until the pH reaches baseline levels. Salivary pH levels will be measured with a digital pH meter. The time required for pH recovery will be registered.
The time required for salivary pH recovery after Coca-Cola consumption followed by oral sprays application
时间窗: 1 hour
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will be asked to rinse their mouths with tap water (control) or each of the tested oral foams according to the manufacturer's recommendations. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption, immediately after oral foams/tap water rinse and further every 5 minutes until the pH reaches baseline levels. The pH levels will be measured with a digital pH meter. The time required for pH recovery will be registered.
Minimal value of salivary pH after Coca-Cola consumption
时间窗: 1 hour
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption and further every 5 minutes until the pH reaches baseline levels. Salivary pH levels will be measured with a digital pH meter. The minimal pH value will be registered.
minimal value of salivary pH recovery after Coca-Cola consumption followed by oral sprays application
时间窗: 1 hour
The participants will be asked to hold 20 ml of "coca-cola" in their mouth for 30 seconds. Then, participants will be asked to rinse their mouths with tap water (control) or each of the tested oral foams according to the manufacturer's recommendations. They will be asked to spit saliva into a sterile vial at baseline (before Coca-cola consumption), immediately after Coca-Cola consumption, immediately after oral foams/tap water rinse and further every 5 minutes until the pH reaches baseline levels. The pH levels will be measured with a digital pH meter. The minimal pH value will be registered.
次要结局
未报告次要终点