Oral Hygiene Clinical Trial
— SALPH-MOfficial title:
Comparison of Five Different Salivary Buffering Agents on the Changes in pH of Saliva in a Cohort Previously Exposed to a Test Sweetened Flavored Milk Drink: A Randomized Controlled Crossover Trial
Verified date | December 2018 |
Source | Uttaranchal Dental & Medical Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 5, 2018 |
Est. primary completion date | July 5, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
India | Department of Oral Medicine & Radiology, Uttaranchal Dental & Medical Research Institute | Dehradun | Uttarakhand |
Lead Sponsor | Collaborator |
---|---|
Dr Meru S |
India,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | pH of Saliva 5 minutes after exposure to test flavored milk drink | All subjects will be given 100 ml of test flavored milk drink, Amul Kool® Milk to drink. The subject will sip, swish and swallow the drink within 2 minutes. Five minutes after this, each subject will give unstimulated saliva in a sterile dish for measurement of saliva - 5minutes after exposure to test flavored milk drink. The outcome accessor is blinded to the origin of sample (from which group). | 5 minutes | |
Secondary | pH of Saliva 15 minutes after exposure to test flavored milk drink | All subjects will be given 100 ml of test flavored milk drink, Amul Kool® Milk to drink. The subject will sip, swish and swallow the drink within 2 minutes. Fifteen minutes after this, each subject will give unstimulated saliva in a sterile dish for measurement of saliva - 15minutes after exposure to test flavored milk drink. The outcome accessor is blinded to the origin of sample (from which group). | 15 minutes | |
Secondary | pH of Saliva 30 minutes after exposure to test flavored milk drink | All subjects from all six (5 experimental and 1 comparator) groups will perform assigned intervention at time 15minutes post exposure to test flavored milk drink, Amul Kool® Milk and shall give unstimulated saliva in a sterile dish for measurement of pH -30minutes after exposure to test flavored milk drink or in other words 15minutes after assigned intervention. The outcome accessor is blinded to origin of sample (from which group). | 30 minutes | |
Secondary | pH of Saliva 45 minutes after exposure to test flavored milk drink | All subjects from all six (5 experimental and 1 comparator) groups will perform assigned intervention at time 15minutes post exposure to test flavored milk drink, Amul Kool® Milk and shall give unstimulated saliva in a sterile dish for measurement of pH -45minutes after exposure to test flavored milk drink or in other words 30minutes after assigned intervention. The outcome accessor is blinded to origin of sample (from which group). | 45 minutes | |
Secondary | pH of Saliva 60 minutes after exposure to test flavored milk drink | All subjects from all six (5 experimental and 1 comparator) groups will perform assigned intervention at time 15minutes post exposure to test flavored milk drink, Amul Kool® Milk and shall give unstimulated saliva in a sterile dish for measurement of pH -60minutes after exposure to test flavored milk drink or in other words 45minutes after assigned intervention. The outcome accessor is blinded to origin of sample (from which group). | 60 minutes |
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