Effects of Carbonated Beverage Consumption on Oral pH and Bacterial Proliferation in Adolescents: A Randomized Crossover Clinical Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Mean salivary pH with regular coke
研究概览
简要总结
The objective of this research is to evaluate the oral modifications caused by different types of coke drinks (regular coke and diet coke). The salivary and the dental biofilm pH will be determined in the first minutes after their consumption. Additionally, the bacterial proliferation of dental biofilm will be evaluated.
详细描述
Sugary soft drinks modify oral pH and favor bacterial proliferation and are associated with the development of caries. Information on the effects of consuming carbonated drinks without sucrose is limited.
In this crossover clinical trial, salivary pH and dental biofilm pH will be determined. These will be registered at 0, 5, 10, 15, 30, 45, and 60 min after the participants ingested 355 ml of natural water, soft drink with sucrose, soft drink with aspartame/acesulfame K or carbonated water on different days (1 week between each other). In addition, dental biofilm cultures will be conducted at 0 and 120 minutes after intake of each beverage to determine Streptococcus mutans biofilm formation.
The patients will be invited to participate and informed of the potential risks. Those who signed informed consent and have eligibility requirements will be randomized in a double-blind manner.
The data collection will be carried out in records forms, including verifying the patient's previous conditions, identification data (ID, age, gender,) and possible adverse events. If any adverse effect could exist, the research team will be notified for the implementation of possible changes.
A HANNA HI 221 potentiometer (HANNA Instruments Inc. Woonsocket-RI-USA, Romania) will be used to determine salivary pH and dental biofilm pH. The electrode will be calibrated using buffer solutions of pH 4.0 and 7.0 for correct records. The electrode will be washed with distilled water before and after each sample. The data will be collected by 2 verifiers, guaranteeing that the information obtained is the same as that indicated on the potentiometer; a stopwatch will indicate the exact time for obtaining the pH values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
colors were designated for each drink
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Habitual consumption of soft drinks
- •DMFT (Decayed, Missing, and Filled Teeth) index of at least 3
- •Agree to participate in the study and sign informed consent
- •Parents sign informed consent
- •Any nutritional condition
排除标准
- •Undergoing orthodontic treatment
- •Received a topical application of fluoride during the last 3 months
- •Having a motor disability that interfered with tooth brushing
- •Consuming drugs or being carriers of diseases that cause xerostomia
- •Being under antibiotic therapy during the study period
- •Having active periodontal infections.
研究组 & 干预措施
Natural Water
355 ml of water should be drunk.
- Salivary pH will be determined at 0, 5, 10, 15, 30, 45 and 60 minutes later
- Dental biofilm pH will be determined at 0, 5, 10, 15, 30, 45 and 60 minutes later
- Streptococcus mutans dental biofilm formation ( Colony Forming Units) will be conducted at 0 and 120 minutes later
干预措施: Natural Water (Drug)
Carbonated water
355 ml of carbonated water should be drunk
- Salivary pH will be determined at 0, 5, 10, 15, 30, 45 and 60 minutes later
- Dental biofilm pH will be determined at 0, 5, 10, 15, 30, 45 and 60 minutes later
- Streptococcus mutans dental biofilm formation ( Colony Forming Units) will be conducted at 0 and 120 minutes later
干预措施: Natural Water (Drug)
Aspartame/acesulfame K
355 ml of drink of diet coke should be drunk.
- Salivary pH will be determined at 0, 5, 10, 15, 30, 45 and 60 minutes later
- Dental biofilm pH will be determined at 0, 5, 10, 15, 30, 45 and 60 minutes later
- Streptococcus mutans dental biofilm formation ( Colony Forming Units) will be conducted at 0 and 120 minutes later
干预措施: Natural Water (Drug)
Saccharose
355 ml of drink of regular coke should be drunk
- Salivary pH will be determined at 0, 5, 10, 15, 30, 45 and 60 minutes later
- Dental biofilm pH will be determined at 0, 5, 10, 15, 30, 45 and 60 minutes later
- Streptococcus mutans dental biofilm formation ( Colony Forming Units) will be conducted at 0 and 120 minutes later
干预措施: Natural Water (Drug)
结局指标
主要结局
Mean salivary pH with regular coke
时间窗: 60 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with diet coke
时间窗: 60 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with carbonated water
时间窗: 60 minutes
logarithm of hydrogen ion concentration
Mean salivary pH with natural water
时间窗: 60 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natual water
时间窗: 45 minutes
Logarithm of hydrogen ion concentration
次要结局
- Mean dental biofilm pH with diet coke(60 minutes)
- Mean dental biofilm pH with natural water(60 minutes)
- Mean dental biofilm pH with regular coke(60 minutes)
- Mean dental pH biofilm with diet coke(15 minutes)
- Mean dental biofilm pH with carbonated water(60 minutes)
- Mean dental biofilm pH with diet carbonated water(5 minutes)
- Mean dental pellicle pH with carbonated water(30 minutes)
研究者
Guadalupe Barajas
Principal Investigator
Hospital Infantil de Mexico Federico Gomez