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

NCT03510962 | Completed DMC

• 2 other identifiers: UDMRI_Sal_pH_FU1111-1212-3732
• 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 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.

Conditions

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

Keywords

pH of saliva; Fruit juice; 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 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 Outcomes (5)

• pH of Saliva 5 minutes after exposure to test mixed fruit juice

  5 minutes

• pH of Saliva 15 minutes after exposure to test mixed fruit juice

  15 minutes

• pH of Saliva 30 minutes after exposure to test mixed fruit juice

  30 minutes

• pH of Saliva 45 minutes after exposure to test mixed fruit juice

  45 minutes

• pH of Saliva 60 minutes after exposure to test mixed fruit juice

  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 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.

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 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.

Other: Group 2: tap water gargle

Group 3: 0.2% chlorhexidine

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 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.

Drug: Group 3: 0.2% Chlorhexidine

Group 4: fluoridated tooth paste

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 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.

Other: Group 4: Fluoridated tooth paste

Group 5: Polyol containing gum

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 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.

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 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.

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 mixed fruit juice 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. 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 DRUG

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.

Also known as: Rexidine®

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. 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.

Also known as: Colgate Total®

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. 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.

Also known as: Orbit®

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. 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 (17)

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  BACKGROUND

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  BACKGROUND

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  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.

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• Arpita Ramisetti, Ramesh Babu M, Kalpana Kotha, Gururam Tej K, Sravani Chirtha. Influence of Salivary pH and Urea Level on Calculus Formation - A Clinical Study. Carib.j.SciTech, 2; 503-508,2014

  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.

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

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  BACKGROUND

MeSH Terms

Interventions

Chlorhexidine; hydrated silica gel-based toothpaste

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: April 27, 2018
• Study Start: April 25, 2018
• Primary Completion: July 5, 2018
• Study Completion: December 5, 2018
• Last Updated: December 6, 2018

Record last verified: 2018-12

Locations

IN (1)