Oral DiseaseNCT03919838
Effect of Probiotic on Oral Health of Children
A study testing Probiotics in people with Oral Disease, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of the randomized, double-blind clinical trial with placebo is to answer the clinical question , or in children with diagnosed childhood early caries the use of L.salivarius and cranberry contained in NutroPharma lozenges will reduce new carious lesions and reduce the titre of the carcinogenic bacteria… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Disease
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 19 Jul 2019to Dec 2019
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- generally healthy children aged 3-6;
- recognized caries of early childhood, dmf> 1,
- lack of active caries and inflammation of the mouth
- colony forming unit CFU > 105 / ml Streptococcus mutans
- a minimum of one-month period from: the last antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations, the use of fluoride toothpaste, not using xylitol, written consent of parents / legal guardians for participation in research.
Who cannot join
- chronic diseases and chronically taken medicines in the past,
- planned change of residence during the year,
- age below 3 and above 6 years,
- healthy teeth, dmf = 0,
- colony forming unit CFU <105 / ml Streptococcus mutans
- Patient during antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations
Show all 9Show fewer
- no toothpaste with fluoride
- using xylitol
- lack of written consent of parents / legal guardians for participation in research.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Dorota Olczak-Kowalczyk
Warsaw, Warsaw, 18 Miodowa Saint, 00-246
Dorota Olczak-Kowalczyk, Ass.Prof., +48 22 502 20 31, pedodoncja@wum.edu.pl
Anna Turska-Szybka, Phd, MD
About this study
Official title: Effect of Probiotic Lactobacillus Salivarius and Cranberry on Oral Health of Children
The aim of the randomized, double-blind clinical trial with placebo is to answer the clinical question , or in children with diagnosed childhood early caries the use of L.salivarius and cranberry contained in NutroPharma lozenges will reduce new carious lesions and reduce the titre of the carcinogenic bacteria Streptococcus mutans, compared to the control group in which the placebo will be administered? The main end point will be to reduce the titre of cariogenic bacteria.
Read the detailed description
Probiotic bacteria are used in the prevention and treatment of gastrointestinal diseases and infections, including the treatment of oral diseases. Probiotic bacteria can be found in saliva, plaque and adhering directly to the mucous membrane. They compete with cariogenic bacteria and pathogens of periodontal disease. Increased interest in probiotics means that attempts are being made to find new solutions regarding the methods of their administration. The use of probiotic bacteria brings beneficial health effects. Lactobacillus salivarius is a strain isolated from human milk. It is inactive (heat treatment) and therefore does not produce metabolites that can promote the formation of carious lesions in the mouth by lowering the mouth potential of hydrogen.
- Conditions
- Oral Disease
- Being tested
- Probiotics, Placebo - No probiotics
- Keywords
- probiotic, oral health, children
- Medical subject headings
- Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
A half of the participants will be randomly allocated to the probiotics group. They will receive two probiotics lozenge before falling asleep for 8 weeks. Clinical examination will be conducted before study and after 8 weeks.
Placebo - No probioticsDietary supplement
A half of the participants will be randomly allocated to the placebo group. They will receive two no probiotics lozenge before falling asleep for 8 weeks. Clinical examination will be conducted before study and after 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Active comparator | Participants will receive two lozenges containing probiotic bacteria and cranberry. Receives: Dietary Supplement: Probiotics |
| Placebo - No probiotics | Placebo comparator | Participants will receive a control two lozenges containing no probiotic bacteria. Receives: Dietary Supplement: Placebo - No probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing the titre of the carcinogenic bacteria Streptococcus mutans
During control tests saliva will be applied to the medium for identification and detailed quantification of S. mutans bacteria. After the incubation, the number of bacteria will be expressed - taking into account the degree of saliva dilution - as the number of colony-forming unit (CFU) in 1 ml of saliva.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start19 Jul 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- NutroPharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919838
- Sponsor's protocol ID
- KB/232/2016
- Status last verified
- Jun 2019
- First submitted
- 15 Apr 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Lactobacillus Salivarius and Cranberry on Oral Health of Children
- ClinicalTrials.gov ID
- NCT03919838
- Acronym / sponsor ID
- KB/232/2016
- Conditions
- Oral Disease
- Keywords
- probiotic, oral health, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- NutroPharma
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Apr 2019 (actual)
- 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.
The aim of the randomized, double-blind clinical trial with placebo is to answer the clinical question , or in children with diagnosed childhood early caries the use of L.salivarius and cranberry contained in NutroPharma lozenges will reduce new carious lesions and reduce the titre of the carcinogenic bacteria Streptococcus mutans, compared to the control group in which the placebo will be administered? The main end point will be to reduce the titre of cariogenic bacteria.
Detailed description
Probiotic bacteria are used in the prevention and treatment of gastrointestinal diseases and infections, including the treatment of oral diseases. Probiotic bacteria can be found in saliva, plaque and adhering directly to the mucous membrane. They compete with cariogenic bacteria and pathogens of periodontal disease. Increased interest in probiotics means that attempts are being made to find new solutions regarding the methods of their administration. The use of probiotic bacteria brings beneficial health effects. Lactobacillus salivarius is a strain isolated from human milk. It is inactive (heat treatment) and therefore does not produce metabolites that can promote the formation of carious lesions in the mouth by lowering the mouth potential of hydrogen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: ProbioticsParticipants will receive two lozenges containing probiotic bacteria and cranberry. |
| Placebo - No probiotics | Placebo comparator | Dietary Supplement: Placebo - No probioticsParticipants will receive a control two lozenges containing no probiotic bacteria. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- generally healthy children aged 3-6;
- recognized caries of early childhood, dmf> 1,
- lack of active caries and inflammation of the mouth
- colony forming unit CFU > 105 / ml Streptococcus mutans
- a minimum of one-month period from: the last antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations, the use of fluoride toothpaste, not using xylitol, written consent of parents / legal guardians for participation in research.
Key exclusion criteria (9 listed)
- chronic diseases and chronically taken medicines in the past,
- planned change of residence during the year,
- age below 3 and above 6 years,
- healthy teeth, dmf = 0,
- colony forming unit CFU <105 / ml Streptococcus mutans
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 |
|---|---|---|
| ProbioticsA half of the participants will be randomly allocated to the probiotics group. They will receive two probiotics lozenge before falling asleep for 8 weeks. Clinical examination will be conducted before study and after 8 weeks. | Dietary supplement | Probiotics |
| Placebo - No probioticsA half of the participants will be randomly allocated to the placebo group. They will receive two no probiotics lozenge before falling asleep for 8 weeks. Clinical examination will be conducted before study and after 8 weeks. | Dietary supplement | Placebo - No probiotics |
Primary outcome
Changing the titre of the carcinogenic bacteria Streptococcus mutans
Time frame: 8 weeks
During control tests saliva will be applied to the medium for identification and detailed quantification of S. mutans bacteria. After the incubation, the number of bacteria will be expressed - taking into account the degree of saliva dilution - as the number of colony-forming unit (CFU) in 1 ml of saliva.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Oral Disease, run by Medical University of Warsaw at 1 site in Poland.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 Oct 2019. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changing the titre of the carcinogenic bacteria Streptococcus mutans (time frame: 8 weeks). 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 31 Oct 2019.