CI

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
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03526770
NCT03526770N/ACompleted

Comparison of Five Different Salivary Buffering Agents on the Changes in Salivary pH in a Cohort Previously Exposed to a Test Carbonated Drink: A Randomized Controlled Crossover Trial.

Dr Meru S·interventional·Posted May 16, 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 acidic and sweetened food and beverage is known to reduce the salivary pH and some of them 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 select commercially available test carbonated drink containing sugar on the salivary pH and assess the buffering capacity of the saliva with or without various intervention measures following the exposure to the test carbonated drink at different time intervals.

Study Details

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

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 16, 2018
Enrollment StartMay 28, 2018
Primary CompletionJul 5, 2018
Study CompletionDec 5, 2018
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 8.1 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 carbonated 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. 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 gum 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.