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

NCT03513575 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-12-06

No results posted yet for this study

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

Interventions

OTHER

Group 1: no intervention

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.

OTHER

Group 2: tap water gargle

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.

OTHER

Group 3: 0.2% Chlorhexidine

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.

OTHER

Group 4: Fluoridated tooth paste

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.

OTHER

Group 5: Polyol containing gum

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.

OTHER

Group 6: 1% sodium bicarbonate solution

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.

Sponsors & Collaborators

  • Dr Meru S

    lead OTHER

Principal Investigators

  • Meru S, MDS · Uttaranchal Dental & Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2018-07-05
Completion
2018-12-05

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03513575 on ClinicalTrials.gov