Saliva AlteredSALPH-MNCT03513575
Comparison of 5 Buffering Agents on Changes in Salivary pH in Individuals Previously Exposed to a Test Flavoured Milk
A study testing Group 2: tap water gargle, Group 3: 0.2% Chlorhexidine and Group 4: Fluoridated tooth paste in people with Saliva Altered and Oral Hygiene, run by Dr Meru S at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Saliva Altered, Oral Hygiene, pH
- What is being tested?
- Group 2: tap water gargle, Group 3: 0.2% Chlorhexidine and Group 4: Fluoridated tooth paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2018to 5 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Oral Medicine & Radiology, Uttaranchal Dental & Medical Research Institute
Dehradun, Uttarakhand, 248140
About this study
Official title: 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
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.
Read the 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)
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:
- 0.2% Chlorhexidine mouth wash (Rexidine®, Indoco Remidies Ltd, Mumbai, India)- 10 ml solution swish for 60 sec and spit
- Tap water- 10ml swish for 60 sec and spit
- Brushing with fluoridated (Colgate Total®, Colgate-Palmolive Company, Mumbai, India) tooth paste- 2min using soft brush
- Chewing polyol containing gum (Orbit®, Wrigley Company)- chew for 5 minutes and spit
- 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.
- Conditions
- Saliva Altered, Oral Hygiene, pH, Tooth Structure; Disorder
- Being tested
- Group 1: no intervention, Group 2: tap water gargle, Group 3: 0.2% Chlorhexidine, Group 4: Fluoridated tooth paste, Group 5: Polyol containing gum
- Keywords
- pH of saliva, Flavored Milk, buffering agent, oral hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: no interventionOther
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.
Group 2: tap water gargleOther
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.
Group 3: 0.2% ChlorhexidineOther
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.
Group 4: Fluoridated tooth pasteOther
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.
Group 5: Polyol containing gumOther
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.
Group 6: 1% sodium bicarbonate solutionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: no intervention | Active comparator | 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. Receives: Other: Group 1: no intervention |
| Group 2: tap water gargle | Experimental | 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. Receives: Other: Group 2: tap water gargle |
| Group 3: 0.2% chlorhexidine | Experimental | 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. Receives: Other: Group 3: 0.2% Chlorhexidine |
| Group 4: fluoridated tooth paste | Experimental | 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. Receives: Other: Group 4: Fluoridated tooth paste |
| Group 5: Polyol containing gum | Experimental | 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. Receives: Other: Group 5: Polyol containing gum |
| Group 6: 1% sodium bicarbonate solution | Experimental | 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. Receives: Other: Group 6: 1% sodium bicarbonate solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH of saliva at baseline
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).
Measured: 0 minute
Secondary outcomes (5)
pH of Saliva 5 minutes after exposure to test flavored milk drink
All subjects will be given 100 ml of test flavored milk drink, Amul Kool® Milk 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 flavored milk drink. The outcome accessor is blinded to the origin of sample (from which group).
Measured: 5 minutes
pH of Saliva 15 minutes after exposure to test flavored milk drink
All subjects will be given 100 ml of test flavored milk drink, Amul Kool® Milk to drink. The subject will sip, swish and swallow the drink within 2 minutes. Fifteen minutes after this, each subject will give unstimulated saliva in a sterile dish for measurement of saliva - 15minutes after exposure to test flavored milk drink. The outcome accessor is blinded to the origin of sample (from which group).
Measured: 15 minutes
pH of Saliva 30 minutes after exposure to test flavored milk drink
All subjects from all six (5 experimental and 1 comparator) groups will perform assigned intervention at time 15minutes post exposure to test flavored milk drink, Amul Kool® Milk and shall give unstimulated saliva in a sterile dish for measurement of pH -30minutes after exposure to test flavored milk drink or in other words 15minutes after assigned intervention. The outcome accessor is blinded to origin of sample (from which group).
Measured: 30 minutes
pH of Saliva 45 minutes after exposure to test flavored milk drink
All subjects from all six (5 experimental and 1 comparator) groups will perform assigned intervention at time 15minutes post exposure to test flavored milk drink, Amul Kool® Milk and shall give unstimulated saliva in a sterile dish for measurement of pH -45minutes after exposure to test flavored milk drink or in other words 30minutes after assigned intervention. The outcome accessor is blinded to origin of sample (from which group).
Measured: 45 minutes
pH of Saliva 60 minutes after exposure to test flavored milk drink
All subjects from all six (5 experimental and 1 comparator) groups will perform assigned intervention at time 15minutes post exposure to test flavored milk drink, Amul Kool® Milk and shall give unstimulated saliva in a sterile dish for measurement of pH -60minutes after exposure to test flavored milk drink or in other words 45minutes after assigned intervention. The outcome accessor is blinded to origin of sample (from which group).
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 May 2018
- Primary completion5 Jul 2018
- Study completion5 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Saliva AlteredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Meru S
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Meru S, Uttaranchal Dental & Medical Research Institute
- Investigators
- Meru S, MDS, Principal investigator, Uttaranchal Dental & Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513575
- Sponsor's protocol ID
- UDMRI_Sal_pH_M
- Other IDs
- U1111-1212-4324
- Acronym
- SALPH-M
- Status last verified
- Dec 2018
- First submitted
- 17 Apr 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sudeep C B, Vipin Jain, Mathew Maliyil , Peter Simon Sequeira, Jithesh Jain. Effects on pH Value of Saliva Following Intake of Three Beverages Containing Apple Juice - A Double Blind Cross- Over Study. National Journal of Medical and Dental Research 1(4): 18-23,2013
Choi SE, Kim HS. Sodium Bicarbonate Solution versus Chlorhexidine Mouthwash in Oral Care of Acute Leukemia Patients Undergoing Induction Chemotherapy: A Randomized Controlled Trial. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Jun;6(2):60-6. doi: 10.1016/j.anr.2012.05.004. Epub 2012 May 24.
PubMed 25030829Chandel S, Khan MA, Singh N, Agrawal A, Khare V. The effect of sodium bicarbonate oral rinse on salivary pH and oral microflora: A prospective cohort study. Natl J Maxillofac Surg. 2017 Jul-Dec;8(2):106-109. doi: 10.4103/njms.NJMS_36_17.
PubMed 29386812Margaret F. Lemaster. Restore pH balance. Sunstar spotlight, special sponsored supplement. March 2012
Bhavna Jha Kukreja, Vidya Dodwad, Herbal mouth washes- a gift of nature. International Journal of Pharma and Bio Sciences 3(2);46-52:2012
de Almeida Pdel V, Gregio AM, Machado MA, de Lima AA, Azevedo LR. Saliva composition and functions: a comprehensive review. J Contemp Dent Pract. 2008 Mar 1;9(3):72-80.
PubMed 18335122Chitharanjan Shetty, Mitra N Hegde, Darshana Devadiga.Correlation between dental caries with salivary flow, pH and buffering capacity in adult south Idoan population: An in-vitro study.Internationl J Res Ayurveda Pharm 4(2):219-223,2013
Tenuta LM, Fernandez CE, Brandao AC, Cury JA. Titratable acidity of beverages influences salivary pH recovery. Braz Oral Res. 2015;29:S1806-83242015000100234. doi: 10.1590/1807-3107BOR-2015.vol29.0032. Epub 2015 Feb 11.
PubMed 25715032Sudeep CB, Anzil KS Ali, Vivek S, Ambalavanan P, Vivek Suku Ninan, Fajar Ummer. Effects on ph value of saliva following intake of three beverages: A double blind cross-over study. International Journal of Dental and Health Sciences.1(3);18-23:2013
Dawes C. What is the critical pH and why does a tooth dissolve in acid? J Can Dent Assoc. 2003 Dec;69(11):722-4.
PubMed 14653937Ciolino LA, McCauley HA, Fraser DB, Wolnik KA. The relative buffering capacities of saliva and moist snuff: implications for nicotine absorption. J Anal Toxicol. 2001 Jan-Feb;25(1):15-25. doi: 10.1093/jat/25.1.15.
PubMed 11215994Larsen MJ, Nyvad B. Enamel erosion by some soft drinks and orange juices relative to their pH, buffering effect and contents of calcium phosphate. Caries Res. 1999;33(1):81-7. doi: 10.1159/000016499.
PubMed 9831784Hayden, Madison R., The Effect of Cheese on the pH Levels in the Oral Cavity. Honors College Capstone Experience/Thesis Projects. Paper 563.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03513575
- Acronym / sponsor ID
- SALPH-M / UDMRI_Sal_pH_M
- Conditions
- Saliva Altered, Oral Hygiene, pH, Tooth Structure; Disorder
- Keywords
- pH of saliva, Flavored Milk, buffering agent, oral hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr Meru SUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 5 Dec 2018 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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:
- 0.2% Chlorhexidine mouth wash (Rexidine®, Indoco Remidies Ltd, Mumbai, India)- 10 ml solution swish for 60 sec and spit
- Tap water- 10ml swish for 60 sec and spit
- Brushing with fluoridated (Colgate Total®, Colgate-Palmolive Company, Mumbai, India) tooth paste- 2min using soft brush
- Chewing polyol containing gum (Orbit®, Wrigley Company)- chew for 5 minutes and spit
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: no intervention | Active comparator | Other: Group 1: no interventionThe 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. |
| Group 2: tap water gargle | Experimental | Other: Group 2: tap water gargleThe 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. |
| Group 3: 0.2% chlorhexidine | Experimental | Other: Group 3: 0.2% ChlorhexidineThe 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. |
| Group 4: fluoridated tooth paste | Experimental | Other: Group 4: Fluoridated tooth pasteThe 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. |
| Group 5: Polyol containing gum | Experimental | Other: Group 5: Polyol containing gumThe 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. |
| Group 6: 1% sodium bicarbonate solution | Experimental | Other: Group 6: 1% sodium bicarbonate solutionThe 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1: no interventionUnstimulated 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. | Other | Group 1: no intervention |
| Group 2: tap water gargleThe 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. | Other | Group 2: tap water gargle |
| Group 3: 0.2% ChlorhexidineThe 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. | Other | Group 3: 0.2% chlorhexidine |
| Group 4: Fluoridated tooth pasteThe 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. | Other | Group 4: fluoridated tooth paste |
| Group 5: Polyol containing gumThe 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. | Other | Group 5: Polyol containing gum |
| Group 6: 1% sodium bicarbonate solutionThe 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. | Other | Group 6: 1% sodium bicarbonate solution |
Primary outcome
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).
5 secondary outcomes
pH of Saliva 5 minutes after exposure to test flavored milk drink
Time frame: 5 minutes
pH of Saliva 15 minutes after exposure to test flavored milk drink
Time frame: 15 minutes
pH of Saliva 30 minutes after exposure to test flavored milk drink
Time frame: 30 minutes
pH of Saliva 45 minutes after exposure to test flavored milk drink
Time frame: 45 minutes
pH of Saliva 60 minutes after exposure to test flavored milk drink
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- BackgroundSudeep C B, Vipin Jain, Mathew Maliyil , Peter Simon Sequeira, Jithesh Jain. Effects on pH Value of Saliva Following Intake of Three Beverages Containing Apple Juice - A Double Blind Cross- Over Study. National Journal of Medical and Dental Research 1(4): 18-23,2013
- Background: PubMed 25030829Choi SE, Kim HS. Sodium Bicarbonate Solution versus Chlorhexidine Mouthwash in Oral Care of Acute Leukemia Patients Undergoing Induction Chemotherapy: A Randomized Controlled Trial. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Jun;6(2):60-6. doi: 10.1016/j.anr.2012.05.004. Epub 2012 May 24.
- Background: PubMed 29386812Chandel S, Khan MA, Singh N, Agrawal A, Khare V. The effect of sodium bicarbonate oral rinse on salivary pH and oral microflora: A prospective cohort study. Natl J Maxillofac Surg. 2017 Jul-Dec;8(2):106-109. doi: 10.4103/njms.NJMS_36_17.
- BackgroundMargaret F. Lemaster. Restore pH balance. Sunstar spotlight, special sponsored supplement. March 2012
- BackgroundBhavna Jha Kukreja, Vidya Dodwad, Herbal mouth washes- a gift of nature. International Journal of Pharma and Bio Sciences 3(2);46-52:2012
- Background: PubMed 18335122de Almeida Pdel V, Gregio AM, Machado MA, de Lima AA, Azevedo LR. Saliva composition and functions: a comprehensive review. J Contemp Dent Pract. 2008 Mar 1;9(3):72-80.
- BackgroundChitharanjan Shetty, Mitra N Hegde, Darshana Devadiga.Correlation between dental caries with salivary flow, pH and buffering capacity in adult south Idoan population: An in-vitro study.Internationl J Res Ayurveda Pharm 4(2):219-223,2013
- Background: PubMed 25715032Tenuta LM, Fernandez CE, Brandao AC, Cury JA. Titratable acidity of beverages influences salivary pH recovery. Braz Oral Res. 2015;29:S1806-83242015000100234. doi: 10.1590/1807-3107BOR-2015.vol29.0032. Epub 2015 Feb 11.
- BackgroundSudeep CB, Anzil KS Ali, Vivek S, Ambalavanan P, Vivek Suku Ninan, Fajar Ummer. Effects on ph value of saliva following intake of three beverages: A double blind cross-over study. International Journal of Dental and Health Sciences.1(3);18-23:2013
- Background: PubMed 14653937Dawes C. What is the critical pH and why does a tooth dissolve in acid? J Can Dent Assoc. 2003 Dec;69(11):722-4.
- Background: PubMed 11215994Ciolino LA, McCauley HA, Fraser DB, Wolnik KA. The relative buffering capacities of saliva and moist snuff: implications for nicotine absorption. J Anal Toxicol. 2001 Jan-Feb;25(1):15-25. doi: 10.1093/jat/25.1.15.
- Background: PubMed 9831784Larsen MJ, Nyvad B. Enamel erosion by some soft drinks and orange juices relative to their pH, buffering effect and contents of calcium phosphate. Caries Res. 1999;33(1):81-7. doi: 10.1159/000016499.
- Individual participant dataSharing planned: Undecided
Related trials for Saliva Altered
Not yet recruiting
Salivary Flow, pH, and Buffering Capacity in Fixed and Clear Aligner Orthodontic Treatment
Orthodontic Treatment, Saliva
Not yet recruitingObservational study
Salivary Function and Dental Changes During GLP-1 Therapy
Obesity, Dental Erosion
Active, not recruiting
WHNRC (Western Human Nutrition Research Center) Honey Study
Postprandial Glycemia, Metabolic Stress
Recruiting
Application of Neuro-electrostimulation as a Treatment for Patients With Dry Mouth
Saliva Altered
Recruiting
The Effects of Using Augmented Reality (AR) System to Train Foreign Care Workers.
Oral Dryness and Saliva Altered, Oral Manifestations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meru S, MDS principal investigator
Uttaranchal Dental & Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 2: tap water gargle, Group 3: 0.2% Chlorhexidine and Group 4: Fluoridated tooth paste in people with Saliva Altered and Oral Hygiene, run by Dr Meru S at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pH of saliva at baseline (time frame: 0 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03513575, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.