Comparison of Five Different Salivary Buffering Agents on the Changes in pH of Saliva in a Cohort Previously Exposed to a Test Sweetened Flavored Milk Drink: A Randomized Controlled Crossover Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- pH of saliva at baseline
Study Overview
Brief Summary
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 sweetened flavored milk 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 flavored milk drink at different time intervals.
Detailed Description
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 sweetened flavored milk 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 test flavored milk drink at different time intervals.
Aims and Objectives:
- To measure the pH of saliva post-exposure to test sweetened flavored milk 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 test sweetened flavored milk 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 test sweetened flavored milk 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 test sweetened flavored milk drink 15 minutes ago
- To measure the pH of saliva at 15, 30 and 45 minutes after brushing with fluoridated tooth paste and soft brush as a buffering agent in those subjects who had prior exposure to test sweetened flavored milk 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 test sweetened flavored milk 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 test flavored milk 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 test sweetened flavored milk 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 sweetened flavored milk drink)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
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 flavored milk drink, Amul Kool® milk, (Gujarat Cooperative Milk Marketing Federation Ltd.) 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 flavored milk drink.
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.
Intervention: Group 6: 1% sodium bicarbonate solution (Other)
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 flavored milk drink, Amul Kool® milk, (Gujarat Cooperative Milk Marketing Federation Ltd.) 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 flavored milk drink.
Intervention: 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 flavored milk drink, Amul Kool® milk, (Gujarat Cooperative Milk Marketing Federation Ltd.) 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 flavored milk drink.
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.
Intervention: Group 2: tap water gargle (Other)
Group 3: 0.2% chlorhexidine
The subject collects unstimulated saliva in a sterile glass dish for measurement of baseline pH of saliva. The subject is then given 100ml of test flavored milk drink, Amul Kool® milk, (Gujarat Cooperative Milk Marketing Federation Ltd.) 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 flavored milk drink.
The subject will use 10 ml of 0.2% Chlorhexidine mouthrinse (Rexidine®, Indoco Remidies Ltd, Mumbai, India) to swish for 60 seconds and spit. Unstimulated saliva samples are collected thereafter to measure and record the pH of saliva at 15, 30 and 45 minutes after subject completes the gargle as an intervention.
Intervention: Group 3: 0.2% Chlorhexidine (Other)
Group 4: fluoridated tooth paste
The subject collects unstimulated saliva in a sterile glass dish for measurement of baseline pH of saliva. The subject is then given 100 ml of test flavored milk drink, Amul Kool® milk, (Gujarat Cooperative Milk Marketing Federation Ltd.) 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 flavored milk drink.
The subject will brush with fluoridated toothpaste (Colgate Total®, Colgate-Palmolive Co., Mumbai, India) for 2 minutes using soft brush. Unstimulated saliva samples are collected thereafter to measure and record the pH of saliva at 15, 30 and 45 minutes after subject completes the brushing as an intervention.
Intervention: Group 4: Fluoridated tooth paste (Other)
Group 5: Polyol containing gum
The subject collects unstimulated saliva in a sterile glass dish for the measurement of baseline pH of saliva. The subject is then given 100 ml of test flavored milk drink, Amul Kool® milk, (Gujarat Cooperative Milk Marketing Federation Ltd.) 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 flavored milk drink.
The subject will chew polyol containing gum (Orbit®, Wrigley Company) for 5 minutes and spit. Unstimulated saliva samples are thereafter collected from to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes the chewing gum as an intervention.
Intervention: Group 5: Polyol containing gum (Other)
Outcomes
Primary Outcomes
pH of saliva at baseline
Time Frame: 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 Amul Kool® Flavored Milk drink in mouth for 2 minutes and then drinking it The outcome accessor is blinded to origin of sample (from which group).
Secondary Outcomes
- pH of Saliva 45 minutes after exposure to test flavored milk drink(45 minutes)
- pH of Saliva 15 minutes after exposure to test flavored milk drink(15 minutes)
- pH of Saliva 5 minutes after exposure to test flavored milk drink(5 minutes)
- pH of Saliva 30 minutes after exposure to test flavored milk drink(30 minutes)
- pH of Saliva 60 minutes after exposure to test flavored milk drink(60 minutes)
Investigators
Dr Meru S
Prof & Head, Dept of Oral Medicine & Radiology
Uttaranchal Dental & Medical Research Institute