Comparison of 5 Buffering Agents on Changes in Salivary pH in Individuals Previously Exposed to a Test Flavoured Milk

NCT03513575 | Completed DMC

• 2 other identifiers: UDMRI_Sal_pH_MU1111-1212-4324
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Saliva Altered; Oral Hygiene; pH; Tooth Structure; Disorder

Keywords

pH of saliva; Flavored Milk; buffering agent; oral hygiene

Outcome Measures

Primary Outcomes (1)

• 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).

  0 minute

Secondary Outcomes (5)

• pH of Saliva 5 minutes after exposure to test flavored milk drink

  5 minutes

• pH of Saliva 15 minutes after exposure to test flavored milk drink

  15 minutes

• pH of Saliva 30 minutes after exposure to test flavored milk drink

  30 minutes

• pH of Saliva 45 minutes after exposure to test flavored milk drink

  45 minutes

• pH of Saliva 60 minutes after exposure to test flavored milk drink

  60 minutes

Study Arms (6)

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.

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.

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.

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.

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.

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.

Other: Group 6: 1% sodium bicarbonate solution

Interventions

Group 1: no intervention OTHER

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 1: no intervention

Group 2: tap water gargle OTHER

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 2: tap water gargle

Group 3: 0.2% Chlorhexidine OTHER

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 3: 0.2% chlorhexidine

Group 4: Fluoridated tooth paste OTHER

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 4: fluoridated tooth paste

Group 5: Polyol containing gum OTHER

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 5: Polyol containing gum

Group 6: 1% sodium bicarbonate solution OTHER

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.

Group 6: 1% sodium bicarbonate solution

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Meru S: lead

Study Sites (1)

Department of Oral Medicine & Radiology, Uttaranchal Dental & Medical Research Institute

Dehradun, Uttarakhand, 248140, India

Location

Related Publications (13)

• 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

  BACKGROUND

• 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.

  PMID: 25030829 BACKGROUND

• Chandel 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.

  PMID: 29386812 BACKGROUND

• Margaret F. Lemaster. Restore pH balance. Sunstar spotlight, special sponsored supplement. March 2012

  BACKGROUND

• Bhavna Jha Kukreja, Vidya Dodwad, Herbal mouth washes- a gift of nature. International Journal of Pharma and Bio Sciences 3(2);46-52:2012

  BACKGROUND

• 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.

  PMID: 18335122 BACKGROUND

• Chitharanjan 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

• 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.

  PMID: 25715032 BACKGROUND

• Sudeep 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

• 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.

  PMID: 14653937 BACKGROUND

• Ciolino 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.

  PMID: 11215994 BACKGROUND

• Larsen 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.

  PMID: 9831784 BACKGROUND

• Hayden, Madison R., The Effect of Cheese on the pH Levels in the Oral Cavity. Honors College Capstone Experience/Thesis Projects. Paper 563.

  BACKGROUND

MeSH Terms

Interventions

Chlorhexidine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Meru S, MDS

  Uttaranchal Dental & Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof & Head, Dept of Oral Medicine & Radiology

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 1, 2018
• Study Start: May 1, 2018
• Primary Completion: July 5, 2018
• Study Completion: December 5, 2018
• Last Updated: December 6, 2018

Record last verified: 2018-12

Locations

IN (1)