Comparison of 5 Buffering Agents on Changes in Salivary pH in Individuals Previously Exposed to a Test Flavoured Milk
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 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:

        1. To measure the pH of saliva post-exposure to test sweetened flavored milk 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 test sweetened flavored milk
           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 test
           sweetened flavored milk 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 test sweetened flavored milk
           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 test sweetened flavored milk 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 test
           sweetened flavored milk 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 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.

        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 test sweetened flavored milk 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 flavored milk drink that will be selected is Amul Kool® (Gujarat Cooperative Milk
      Marketing Federation Ltd)

      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®, Wrigley Company)- 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 sweetened flavored milk 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 sweetened flavoured milk 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; Other; 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 flavored milk drink without any intervention.; The subject will use 10 ml of tap water as mouth rinse to swish for 60 seconds and spit, 15minutes after the subject has consumed the test flavored milk drink. 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, 15minutes after the subject has consumed the test flavored milk drink. 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, 15minutes after the subject has consumed the test flavored milk drink. 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, 15minutes after the subject has consumed the test flavored milk drink. 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 as an intervention.; The subject will use 10 ml freshly prepared 1% sodium bicarbonate w/v solution to swish for 60 seconds and spit, 15minutes after the subject has consumed the test flavored milk drink. 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 MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: pH of saliva; Flavored Milk; buffering agent; oral hygiene