Comparison of Five Different Salivary Buffering Agents on the Changes in Salivary pH in a Cohort Previously Exposed to a Test Fruit Juice: A Randomized Controlled Crossover Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- pH of saliva at baseline
研究概览
简要总结
The diurnal variation in the flow of saliva and hence the composition of saliva is an established fact. Consumption of most types of acidic and sweetened foods and beverages are known to reduce the pH of saliva and some of them even reduce it to critical pH levels and result in structural damage to the hard tissues of the tooth.
The purpose of this study is to ascertain the effect of the selected commercially available test fruit-juice drink on the salivary pH and assess the buffering capacity of the saliva with or without various intervention measures following the exposure to the test fruit-juice drink at different time intervals.
详细描述
There are substantial existing evidences that there is diurnal variation in the flow of saliva and hence the composition of saliva. The average of normal pH of saliva is reported to be 6.8. Consumption of most types of acidic and sweetened foods and beverages are known to reduce the pH of saliva and some of them even reduce it to critical pH levels and result in structural damage to the hard tissues of the tooth.
Such damages can be prevented by maintaining the pH of saliva within optimal range by using oral hygiene measures.
The purpose of this study is to ascertain the effect of the selected commercially available test fruit-juice drink containing sugar on the pH of saliva and assess the buffering capacity of the saliva with or without various intervention measures following the exposure to the commercially available test fruit-juice drink at different time intervals.
Aims and Objectives:
- To measure the pH of saliva post-exposure to commercially available test fruit-juice drink after 5, 15, 30, 45 and 60 minutes.
- To measure the pH of saliva at 15, 30 and 45 minutes after using a tap water gargle as a buffering agent in those subjects who had prior exposure to commercially available test fruit-juice drink 15 minutes ago.
- To measure the pH of saliva at 15, 30 and 45 minutes after using a 0.2%Chlorhexidine mouth rinse as a buffering agent in those subjects who had prior exposure to commercially available test fruit-juice drink 15 minutes ago.
- To measure the pH of saliva at 15, 30 and 45 minutes after chewing Orbit® gum as a buffering agent in those subjects who had prior exposure to commercially available test fruit-juice drink 15 minutes ago
- To measure the pH of saliva at 15, 30 and 45 minutes after brushing with commercially available fluoridated tooth paste and soft brush as a buffering agent in those subjects who had prior exposure to test fruit-juice drink 15 minutes ago
- To measure the pH of saliva at 15, 30 and 45 minutes after gargling with 1% solution of baking soda as a buffering agent in those subjects who had prior exposure to commercially available test fruit-juice drink 15 minutes ago
- To compare the efficacy of buffering agents on the pH of saliva at 15, 30, 45 minutes post intervention in subjects who have had the commercially available test fruit-juice drink 15 min prior to the a specific intervention, with the pH of saliva recorded in the same subjects at the same time periods when no intervention with any buffering agent was carried out after having the commercially available test fruit-juice drink.
- To compare the pH of saliva recorded in the subjects at 15, 30, 45 minutes time periods when they used an intervention of gargle with tap water, with that recorded when they used mouth rinse of 0.2% Chlorhexidine, with that recorded when they brushed with soft brush and fluoridated tooth paste, with that recorded when they gargled with 1% baking soda solution and with that recorded when they chewed Orbit® chewing gum (15 minutes after using the test fruit-juice drink)
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
- Single (Outcomes Assessor)
盲法说明
only primary investigator will know the intervention done by the subject. The outcome investigator(assessor) will be unaware (blinded) to which intervention the subject is undertaken.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects in the age group of 18 to 30 years.
- •subjects with a DMFT index score of less than
- •subjects with Loe and Silness index score of
- •subjects willing to volunteer for the study.
- •subjects who are available for the whole study period of 4 months
排除标准
- •subjects with history of gastritis and bulimia.
- •subjects with chronic medical illness.
- •subjects with history of allergy.
- •subjects with history of drug intake for last 8 weeks.
- •subjects who smoke or chew tobacco.
研究组 & 干预措施
Group 3: 0.2% chlorhexidine
The subject collects the unstimulated saliva in a sterile glass dish for the measurement of baseline pH of the saliva. The subject is then given 100 ml of test mixed fruit juice, Tropicana® Mixed Fruit Juice, (PepsiCo, Inc) to drink. The subject will sip, swish and swallow the drink within 2 minutes.
Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva after 5 and 15 minutes of consumption of the test mixed fruit juice.
The subject will use 10 ml of 0.2% Chlorhexidine mouth rinse (Rexidine®, Indoco Remidies Ltd, Mumbai, India) to swish for 60 seconds and spit. Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes the gargle as an intervention.
干预措施: Group 3: 0.2% Chlorhexidine (Drug)
Group 1: no intervention
The subject collects the unstimulated saliva in a sterile glass dish for the measurement of baseline pH of the saliva.The subject is then given 100 ml of test mixed fruit juice,Tropicana® Mixed Fruit Juice, (PepsiCo, Inc) to drink. The subject will sip, swish and swallow the drink within 2 minutes.
Unstimulated saliva samples are collected from the subject to measure the pH of saliva after 5, 15, 30, 45 and 60 minutes of consumption of the test mixed fruit juice.
干预措施: Group 1: no intervention (Other)
Group 2: tap water gargle
The subject collects the unstimulated saliva in a sterile glass dish for the measurement of baseline pH of the saliva.The subject is then given 100 ml of test mixed fruit juice,Tropicana® Mixed Fruit Juice, (PepsiCo, Inc) to drink. The subject will sip, swish and swallow the drink within 2 minutes.
Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva after 5 and 15 minutes of consumption of the test mixed fruit juice.
The subject will use 10 ml of tap water as mouth rinse to swish for 60 seconds and spit. Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes the gargle as an intervention.
干预措施: Group 2: tap water gargle (Other)
Group 4: fluoridated tooth paste
The subject collects the unstimulated saliva in a sterile glass dish for the measurement of baseline pH of the saliva. The subject is then given 100 ml of test mixed fruit juice, Tropicana® Mixed Fruit Juice, (PepsiCo, Inc) to drink. The subject will sip, swish and swallow the drink within 2 minutes.
Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva after 5 and 15 minutes of consumption of the test mixed fruit juice.
The subject will Brush with fluoridated toothpaste (Colgate Total®, Colgate-Palmolive Company, Mumbai, India) for 2 minutes using soft brush.
Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes the brushing as an intervention.
干预措施: Group 4: Fluoridated tooth paste (Other)
Group 5: Polyol containing gum
The subject collects the unstimulated saliva in a sterile glass dish for the measurement of baseline pH of the saliva. The subject is then given 100 ml of test mixed fruit juice, Tropicana® Mixed Fruit Juice, (PepsiCo, Inc) to drink. The subject will sip, swish and swallow the drink within 2 minutes.
Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva after 5 and 15 minutes of consumption of the test mixed fruit juice.
The subject will chew polyol containing gum (Orbit®, Wrigley Company) for 5 minutes and spit.
Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes the chewing gum as an intervention.
干预措施: Group 5: Polyol containing gum (Other)
Group 6: 1% sodium bicarbonate solution
The subject collects the unstimulated saliva in a sterile glass dish for the measurement of baseline pH of the saliva. The subject is then given 100 ml of test mixed fruit juice, Tropicana® Mixed Fruit Juice, (PepsiCo, Inc) to drink. The subject will sip, swish and swallow the drink within 2 minutes.
Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva after 5 and 15 minutes of consumption of the test mixed fruit juice.
The subject will use 10 ml freshly prepared 1% sodium bicarbonate w/v solution to swish for 60 seconds and spit.
Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes the gargle as an intervention.
干预措施: Group 6: 1% sodium bicarbonate solution (Other)
结局指标
主要结局
pH of saliva at baseline
时间窗: 0 minute
All subjects in all groups collects the unstimulated saliva in a sterile glass dish for the measurement of baseline pH of the saliva. The subject will give the saliva sample just before being exposed to the test mixed fruit juice by swishing 100ml of Tropicana® Mixed Fruit Juice in mouth for 2 minutes and then drinking it The outcome accessor is blinded to origin of sample (from which group).
次要结局
- pH of Saliva 30 minutes after exposure to test mixed fruit juice(30 minutes)
- pH of Saliva 5 minutes after exposure to test mixed fruit juice(5 minutes)
- pH of Saliva 45 minutes after exposure to test mixed fruit juice(45 minutes)
- pH of Saliva 15 minutes after exposure to test mixed fruit juice(15 minutes)
- pH of Saliva 60 minutes after exposure to test mixed fruit juice(60 minutes)
研究者
Dr Meru S
Prof & Head, Dept of Oral Medicine & Radiology
Uttaranchal Dental & Medical Research Institute