Dental CariesNCT01943123
Effect of Probiotic Drink on Number of Salivary Mutans Streptococci in School Going Children
A study testing probiotic drink in people with Dental Caries, run by The Oxford Dental College, Hospital and Research Center, Bangalore, India at 1 site in India.
Trial summary
This study was conducted to assess the effects of commercially available probiotic drink on the number of salivary mutans streptococci in school going children, aged 12-14 years in Bangalore city in India Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- probiotic drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2011to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- no active carious lesion
- restored dental cavities
- on no systemic antibiotic medication 6 weeks before commencing the study
Who cannot join
- habitual consumers of probiotics or xylitol chewing gums
- recent exposure to topical/ systemic fluoride treatment
- undergoing any orthodontic treatment during the entire study tenure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Commercially Available Probiotic Drink on Number of Salivary Mutans Streptococci in School Going Children Aged 12-14 Years in Bangalore City (India): Randomized Controlled Trial
This study was conducted to assess the effects of commercially available probiotic drink on the number of salivary mutans streptococci in school going children, aged 12-14 years in Bangalore city in India
Read the detailed description
Probiotic bacteria are thought to reduce the risk of diseases in oral cavity, namely dental caries. Studies have suggested that oral cavity can benefit immensely from these friendly bacteria, although more clinical trials are needed to establish concrete results. Hence, this study was undertaken as a 6 month clinical trial to assess the effects of probiotic on the most frequent resident of oral micro flora- the mutans streptococci.
Method- Design: parallel arm design Sample size: 60 subjects (30 subjects in each group) Duration: 6 months
Material used- Intervention/manipulation: 50ml commercially available probiotic drink for one group (30 subjects in study group) and 50 ml of plain, unsweetened and unflavored milk to control group (30 subjects in control group)for a period of 6 months.
Indices used: plaque index- Turskey Gilmore-Glikman modification of Quigley-Hein, Plaque Index (1970)
Gingival Index-Loe.H and Silness P. gingival index (1963)
Both the indices were used twice, at the start of the study, that is, to collect base line data and at the end of the intervention period (6 months)as final data collected.
Sample collection: stimulated saliva was collected (5ml) and analyzed for CFU of streptococcus mutans and lactobacilli at the start of the study and after 6 months, at the end of the intervention.
Statistical analysis: students t test, fisher exact test and chi-square test were used to compare the baseline data with the final data collected at the end of the intervention.
- Conditions
- Dental Caries
- Being tested
- probiotic drink, Placebo Comparator: plain, unsweetend, unflavored pasturised milk
- Keywords
- probiotics,, streptococcus mutans,, lactobacilli,, plaque index,, gingival index
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic drinkDietary supplement
Also called yakult probiotic drink
comparison of study group (probiotic group) with the control group regarding the number of CFU of microbes in oral cavity and the overall oral health status measured using indices
Placebo Comparator: plain, unsweetend, unflavored pasturised milkDietary supplement
comparison of control group with the study group (probiotic group) regarding the number of CFU of microbes in oral cavity and the overall oral health status measured using indices
| Study group | Role | What they receive |
|---|---|---|
| probiotic drink | Experimental | experimental group (30 subjects) were given 50 ml of probiotic drink for 6 months on daily basis Receives: Dietary Supplement: probiotic drink |
| plain, unsweetend, unflavored pasturised milk | Placebo comparator | control group/ placebo group (30 subjects) were given pasteurized milk (50 ml) for 6 months on regular basis Receives: Dietary Supplement: Placebo Comparator: plain, unsweetend, unflavored pasturised milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
saliva samples were tested for CFU for streptococci mutans and lactobacilli
Saliva samples were tested and the results reveled that number of CFU for both streptococci mutans and lactobacilli varied significantly at the baseline and post intervention in study group (subjects who received probiotic drink). There was reduction in number of CFU of streptococci mutans and lactobacilli in study group.
Measured: feburary 2011 and july 2011 (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startFeb 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Oxford Dental College, Hospital and Research Center, Bangalore, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Aman deep Pabbla, The Oxford Dental College, Hospital and Research Center, Bangalore, India
- Investigators
- vani shree nanjundaiah, MDS, Study director, The Oxford Dental College, Bangalore, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943123
- Sponsor's protocol ID
- vani-1
- Status last verified
- Sep 2013
- First submitted
- 5 Sep 2013
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Commercially Available Probiotic Drink on Number of Salivary Mutans Streptococci in School Going Children Aged 12-14 Years in Bangalore City (India): Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01943123
- Acronym / sponsor ID
- vani-1
- Conditions
- Dental Caries
- Keywords
- probiotics,, streptococcus mutans,, lactobacilli,, plaque index,, gingival index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Oxford Dental College, Hospital and Research Center, Bangalore, IndiaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to assess the effects of commercially available probiotic drink on the number of salivary mutans streptococci in school going children, aged 12-14 years in Bangalore city in India
Detailed description
Probiotic bacteria are thought to reduce the risk of diseases in oral cavity, namely dental caries. Studies have suggested that oral cavity can benefit immensely from these friendly bacteria, although more clinical trials are needed to establish concrete results. Hence, this study was undertaken as a 6 month clinical trial to assess the effects of probiotic on the most frequent resident of oral micro flora- the mutans streptococci.
Method- Design: parallel arm design Sample size: 60 subjects (30 subjects in each group) Duration: 6 months
Material used- Intervention/manipulation: 50ml commercially available probiotic drink for one group (30 subjects in study group) and 50 ml of plain, unsweetened and unflavored milk to control group (30 subjects in control group)for a period of 6 months.
Indices used: plaque index- Turskey Gilmore-Glikman modification of Quigley-Hein, Plaque Index (1970)
Gingival Index-Loe.H and Silness P. gingival index (1963)
Both the indices were used twice, at the start of the study, that is, to collect base line data and at the end of the intervention period (6 months)as final data collected.
Sample collection: stimulated saliva was collected (5ml) and analyzed for CFU of streptococcus mutans and lactobacilli at the start of the study and after 6 months, at the end of the intervention.
Statistical analysis: students t test, fisher exact test and chi-square test were used to compare the baseline data with the final data collected at the end of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic drink | Experimental | Dietary Supplement: probiotic drinkexperimental group (30 subjects) were given 50 ml of probiotic drink for 6 months on daily basis |
| plain, unsweetend, unflavored pasturised milk | Placebo comparator | Dietary Supplement: Placebo Comparator: plain, unsweetend, unflavored pasturised milkcontrol group/ placebo group (30 subjects) were given pasteurized milk (50 ml) for 6 months on regular basis |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- no active carious lesion
- restored dental cavities
- on no systemic antibiotic medication 6 weeks before commencing the study
Key exclusion criteria (3 listed)
- habitual consumers of probiotics or xylitol chewing gums
- recent exposure to topical/ systemic fluoride treatment
- undergoing any orthodontic treatment during the entire study tenure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotic drinkAlso: yakult probiotic drinkcomparison of study group (probiotic group) with the control group regarding the number of CFU of microbes in oral cavity and the overall oral health status measured using indices | Dietary supplement | probiotic drink |
| Placebo Comparator: plain, unsweetend, unflavored pasturised milkcomparison of control group with the study group (probiotic group) regarding the number of CFU of microbes in oral cavity and the overall oral health status measured using indices | Dietary supplement | plain, unsweetend, unflavored pasturised milk |
Primary outcome
saliva samples were tested for CFU for streptococci mutans and lactobacilli
Time frame: feburary 2011 and july 2011 (6 months)
Saliva samples were tested and the results reveled that number of CFU for both streptococci mutans and lactobacilli varied significantly at the baseline and post intervention in study group (subjects who received probiotic drink). There was reduction in number of CFU of streptococci mutans and lactobacilli in study group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
vani shree nanjundaiah, MDS study director
The Oxford Dental College, Bangalore, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic drink in people with Dental Caries, run by The Oxford Dental College, Hospital and Research Center, Bangalore, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
saliva samples were tested for CFU for streptococci mutans and lactobacilli (time frame: feburary 2011 and july 2011 (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2013.