Comparison of 5 Buffering Agents on Changes in Salivary pH in Individuals Previously Exposed to a Test Carbonated Drink
Condition: Saliva Altered; Oral Hygiene; pH; Tooth Structure; Disorder
Study type: Interventional

Summary: 
      The diurnal variation in the flow of saliva and hence the composition of saliva is an
      established fact. Consumption of acidic and sweetened food and beverage is known to reduce
      the salivary pH and some of them 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 select commercially available
      test carbonated drink containing sugar on the salivary pH and assess the buffering capacity
      of the saliva with or without various intervention measures following the exposure to the
      test carbonated 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 acidic and sweetened food and beverage is known to reduce the salivary
      pH and some of them 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 salivary pH
      within optimal range by using oral hygiene measures.

      The purpose of this study is to ascertain the effect of the select commercially available
      test carbonated drink containing sugar on the salivary pH and assess the buffering capacity
      of the saliva with or without various intervention measures following the exposure to the
      test carbonated drink at different time intervals.

      Aims and objectives:

        1. To measure the pH of saliva post-exposure to commercially available test carbonated
           drink after 5, 15, 30, 45 and 60 minutes.

        2. 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
           carbonated drink 15 minutes ago.

        3. 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 carbonated drink 15 minutes ago.

        4. 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
           carbonated drink 15 minutes ago

        5. 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 commercially available test carbonated drink 15 minutes ago

        6. 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 carbonated drink 15 minutes ago

        7. 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 carbonated
           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 carbonated drink.

        8. 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 commercially available test carbonated drink)

      Materials and Methods:

      30 volunteers in the age group of 18- 30 year with healthy oral cavities will be selected.

      Subjects with a history of any chronic medical illness, history of allergy, intake of drugs
      in the last 8 weeks, history of gastritis, bulimia will be excluded. Subjects with a DMFT
      score of more than 2 and Loe and Sillness Index of more than 0 will be excluded. Individuals
      who have and are currently undergoing orthodontic treatment will not be included in the
      study. Individuals who smoke or chew tobacco will not be included in the study sample. An
      informed consent for the research will be obtained from all the subjects who have volunteered
      for the study.

      The trial will be conducted as per the guidelines in the WHO-Handbook for Good Clinical
      Practice and the research protocol is approved by the Institutional Ethics Committee of the
      college.

      The test carbonated drink that will be selected is Coco Cola®. The various buffering agents
      that will be used are:

        1. 0.2% Chlorhexidine mouth wash (Rexidine®, Indoco Remidies Ltd, Mumbai, India)- 10 ml
           solution swish for 60 sec and spit

        2. Tap water- 10ml swish for 60 sec and spit

        3. Brushing with fluoridated (Colgate Total®, Colgate-Palmolive Company, Mumbai, India)
           tooth paste- 2min using soft brush

        4. Chewing polyol containing gum (Orbit®, WrigleyCompany)- chew for 5 minutes and spit

        5. Freshly prepared Sodium bicarbonate (baking soda) 1% w/v solution- swish for 60 sec and
           spit The observer who will be recording the salivary pH will remain blinded about the
           samples and buffering agent used.

      The select individuals will be instructed to not use any mouth wash as part of oral hygiene
      regimen on test day and not consume any food or beverage for 2 hours prior to the collection
      of baseline sample of saliva at 10 AM on the test day. The select group of 30 individuals
      will be given a sample of 100 ml of the test carbonated drink after recording their baseline
      salivary pH (0 min). They will be asked to sip, swish and swallow the drink within 2 minutes.
      After the exposure, salivary samples will be collected at 5 min and 15 min intervals for
      assessment of pH. Fifteen minutes after the exposure (consumption of test drink), the
      individuals will be asked to use one of the intervention methods included in this study. The
      salivary samples will be collected after 15, 30 and 45 minutes interval after the
      intervention. (i.e. 30, 45 and 60 minutes post exposure to the test drink respectively) The
      same protocol will be repeated using each intervention methods included in this study after a
      wash out period of minimum of 3 days. The protocol will be repeated on the study sample
      without any intervention following the exposure to the test soft drinks as a control.

      Measurement of salivary pH will be done using a portable PH-035 Digital pH meter with
      automatic temperature compensation, to the accuracy of 0.1 and the machine will be calibrated
      on the morning of every test day and after 60 uses during the test day using Aquasol® pH
      calibration solutions with pH 4, 7 and 10.
    

Intervention name(s): Group 1: no intervention; Group 2: tap water gargle; Group 3: 0.2% Chlorhexidine; Group 4: Fluoridated tooth paste; Group 5: Polyol containing gum; Group 6: 1% sodium bicarbonate solution
Intervention type(s): Other; Other; Drug; Other; Other; Other
Intervention description(s): 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 carbonated drink without any intervention; 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.; 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; 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 using tooth paste as an intervention.; The subject will chew polyol containing gum (Orbit®, WrigleyCompany) 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 chewing gum as an intervention.; 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.
Other intervention name(s): Rexidine®; Colgate Total®; Orbit®
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: pH of saliva; carbonated drink; buffering agent; oral hygiene