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At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Group 3: 0.2% Chlorhexidine +5 moredrug
Likely dose
Group 3: 0.2% Chlorhexidine 10 mlfrom record
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Search/NCT03510962
NCT03510962N/ACompleted

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.

Dr Meru S·interventional·Posted Apr 27, 2018·Updated Dec 6, 2018

In Brief

A clinical study evaluating Group 1: no intervention, Group 2: tap water gargle, and 4 other interventions for Saliva Altered and 3 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 27, 2018
Enrollment StartApr 25, 2018
Primary CompletionJul 5, 2018
Study CompletionDec 5, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.2 years ago

Interventions

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 mixed fruit juice 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. 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% Chlorhexidinedrug

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.

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. 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. 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. 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.