Comparison of 5 Buffering Agents on Changes in Salivary pH in Individuals Previously Exposed to a Test Fruit Juice (SALPH-F)

December 5, 2018 updated by: Dr Meru S

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.

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.

Study Overview

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 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:

  1. To measure the pH of saliva post-exposure to commercially available test fruit-juice 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 fruit-juice 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 fruit-juice 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 fruit-juice drink 15 minutes ago
  5. 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
  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 fruit-juice 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 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.
  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 fruit-juice 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 fruit-juice drink that will be selected is Tropicana® Mixed Fruit Juice®.

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 measuring 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 Tropicana® mixed fruit-juice 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 fruit juice 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Uttarakhand
      • Dehradun, Uttarakhand, India, 248140
        • Department of Oral Medicine & Radiology, Uttaranchal Dental & Medical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subjects in the age group of 18 to 30 years.
  • subjects with a DMFT index score of less than 2.
  • subjects with Loe and Silness index score of 0.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.

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 without any intervention.
Experimental: 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.

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.
Experimental: 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.

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.
Other Names:
  • Rexidine®
Experimental: 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.

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.

Other Names:
  • Colgate Total®
Experimental: 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.

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 as an intervention.

Other Names:
  • Orbit®
Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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).
0 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pH of Saliva 5 minutes after exposure to test mixed fruit juice
Time Frame: 5 minutes
All subjects will be given 100 ml of test mixed fruit juice, Tropicana® Mixed Fruit Juice to drink. The subject will sip, swish and swallow the drink within 2 minutes. Five minutes after this, each subject will give unstimulated saliva in a sterile dish for measurement of saliva - 5minutes after exposure to test mixed fruit juice. The outcome accessor is blinded to the origin of sample (from which group).
5 minutes
pH of Saliva 15 minutes after exposure to test mixed fruit juice
Time Frame: 15 minutes
All subjects will give unstimulated saliva in a sterile dish for measurement of saliva -15minutes after exposure to test mixed fruit juice. The outcome accessor is blinded to the origin of sample (from which group).
15 minutes
pH of Saliva 30 minutes after exposure to test mixed fruit juice
Time Frame: 30 minutes
All subjects from all six (5 test and 1 comparator) groups will perform the assigned intervention as per schedule at time 15minutes post exposure to mixed fruit juice and shall give unstimulated saliva in a sterile dish for measurement of saliva -30minutes after exposure to test mixed fruit juice or in other words 15minutes after assigned intervention. The outcome accessor is blinded to the origin of sample (from which group).
30 minutes
pH of Saliva 45 minutes after exposure to test mixed fruit juice
Time Frame: 45 minutes
All subjects from all six (5 test and 1 comparator) groups will perform the assigned intervention as per given schedule at time 15minutes post exposure to mixed fruit juice and shall give unstimulated saliva in a sterile dish for measurement of saliva -45minutes after exposure to test mixed fruit juice or in other words 30minutes after assigned intervention. The outcome accessor is blinded to the origin of sample (from which group).
45 minutes
pH of Saliva 60 minutes after exposure to test mixed fruit juice
Time Frame: 60 minutes
All subjects from all six (5 test and 1 comparator) groups will perform the assigned intervention as per given schedule at time 15 minutes post exposure to mixed fruit juice and shall give unstimulated saliva in a sterile dish for measurement of saliva -60minutes after exposure to test mixed fruit juice or in other words 45minutes after assigned intervention. The outcome accessor is blinded to the origin of sample (from which group).
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2018

Primary Completion (Actual)

July 5, 2018

Study Completion (Actual)

December 5, 2018

Study Registration Dates

First Submitted

April 17, 2018

First Submitted That Met QC Criteria

April 17, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Actual)

December 6, 2018

Last Update Submitted That Met QC Criteria

December 5, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • UDMRI_Sal_pH_F
  • U1111-1212-3732 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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