Streptococcal InfectionsPhase 1/2NCT02052973
Efficacy of Propolis Varnish Against Oral Biofilm
A Phase 1/2 study testing Propolis varnish in people with Streptococcal Infections and Saliva Altered, run by Federal University of Minas Gerais.
Trial summary
This study aims to evaluate the effectiveness of a varnish containing 15% of green propolis on Streptococcus mutans in saliva and biofilm. Will be invited to join the study: children 8-10 years old, free of caries, without orthodontic appliances and without having undergone antibiotic therapy until three weeks before… Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Streptococcal Infections, Saliva Altered
- What is being tested?
- Propolis varnish
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jul 2015
- Phase
- Phase 1/2
- 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children 8-10 years old
- good general health condition
- not making use of mouthwashes or medications (especially antibiotics), until three weeks prior to the beginning of the experiment.
Who cannot join
- Patients in medical treatment or who used drugs (especially antibiotics), in the three previous weeks and patients with active caries lesions.
About this study
Official title: Efficacy of Brazilian Green Propolis Varnish Against Streptococcus Mutans in Saliva: a Phase II Study.
This study aims to evaluate the effectiveness of a varnish containing 15% of green propolis on Streptococcus mutans in saliva and biofilm. Will be invited to join the study: children 8-10 years old, free of caries, without orthodontic appliances and without having undergone antibiotic therapy until three weeks before the start of the study. Saliva will be collected before, immediately after, 24 hours and 30 days after application of the varnish. The collection of biofilm will be performed before, after, 24 hours and 30 days after application of the varnish. Data will be collected and compared between periods.
Read the detailed description
Antimicrobials are substances used in dentistry as an efficient way of caries prevention. Substances such as chlorhexidine are the most known and most applied for this purpose and, as a varnish, increased its anticariogenic potential. The antimicrobial effects of natural substances are being studied for exhibiting antimicrobial properties similar to those of chlorhexidine, but less toxic in some cases. Several studies with propolis has proven its efficacy against several microorganisms of the oral cavity, specially Streptococcus mutans. A pharmaceutical formulation containing brazilian green propolis was developed based on the chitosan polymer that is biocompatible and biodegradable. In a previous study, we observed in vitro antimicrobial properties of the varnish against Streptococcus mutans. This work aims to study the preliminary evidence of the efficacy of the propolis dental varnish in reducing Streptococcus mutans in saliva and in the biofilm control through a phase II study involving patients with 8-10 years. After 30 days, the results will be compared and statistically analyzed at a level of significance of 5 % .
- Conditions
- Streptococcal Infections, Saliva Altered
- Being tested
- Propolis varnish
- Keywords
- Streptococcus mutans, Natural products
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propolis varnishOther
Saliva and oral biofilm will be collected before and in regular times after the application of the propolis varnish. This data will be compared in order to evaluate the probable reduction of Streptococcus mutans in saliva and oral biofilm.
| Study group | Role | What they receive |
|---|---|---|
| Propolis varnish | Experimental | Saliva and oral biofilm will be collected before and in regular times after the application of the propolis varnish. This data will be compared in order to evaluate the probable reduction of Streptococcus mutans in saliva and oral biofilm. Receives: Other: Propolis varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Streptococcus mutans in saliva and in tooth biofilm
Measured: 30 days
Secondary outcomes (1)
Caries incidence reduction
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcal InfectionsStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Mariana Passos De Luca, Federal University of Minas Gerais
- Investigators
- Mariana P De Luca, DDs MSc, Principal investigator, UFMG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052973
- Sponsor's protocol ID
- 10726612.8.0000.5149
- Status last verified
- Jul 2015
- First submitted
- 29 Jan 2014
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Brazilian Green Propolis Varnish Against Streptococcus Mutans in Saliva: a Phase II Study.
- ClinicalTrials.gov ID
- NCT02052973
- Acronym / sponsor ID
- 10726612.8.0000.5149
- Conditions
- Streptococcal Infections, Saliva Altered
- Keywords
- Streptococcus mutans, Natural products
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Feb 2014 (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 aims to evaluate the effectiveness of a varnish containing 15% of green propolis on Streptococcus mutans in saliva and biofilm. Will be invited to join the study: children 8-10 years old, free of caries, without orthodontic appliances and without having undergone antibiotic therapy until three weeks before the start of the study. Saliva will be collected before, immediately after, 24 hours and 30 days after application of the varnish. The collection of biofilm will be performed before, after, 24 hours and 30 days after application of the varnish. Data will be collected and compared between periods.
Detailed description
Antimicrobials are substances used in dentistry as an efficient way of caries prevention. Substances such as chlorhexidine are the most known and most applied for this purpose and, as a varnish, increased its anticariogenic potential. The antimicrobial effects of natural substances are being studied for exhibiting antimicrobial properties similar to those of chlorhexidine, but less toxic in some cases. Several studies with propolis has proven its efficacy against several microorganisms of the oral cavity, specially Streptococcus mutans. A pharmaceutical formulation containing brazilian green propolis was developed based on the chitosan polymer that is biocompatible and biodegradable. In a previous study, we observed in vitro antimicrobial properties of the varnish against Streptococcus mutans. This work aims to study the preliminary evidence of the efficacy of the propolis dental varnish in reducing Streptococcus mutans in saliva and in the biofilm control through a phase II study involving patients with 8-10 years. After 30 days, the results will be compared and statistically analyzed at a level of significance of 5 % .
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propolis varnish | Experimental | Other: Propolis varnishSaliva and oral biofilm will be collected before and in regular times after the application of the propolis varnish. This data will be compared in order to evaluate the probable reduction of Streptococcus mutans in saliva and oral biofilm. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children 8-10 years old
- good general health condition
- not making use of mouthwashes or medications (especially antibiotics), until three weeks prior to the beginning of the experiment.
Key exclusion criteria (1 listed)
- Patients in medical treatment or who used drugs (especially antibiotics), in the three previous weeks and patients with active caries lesions.
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 |
|---|---|---|
| Propolis varnishSaliva and oral biofilm will be collected before and in regular times after the application of the propolis varnish. This data will be compared in order to evaluate the probable reduction of Streptococcus mutans in saliva and oral biofilm. | Other | Propolis varnish |
Primary outcome
Streptococcus mutans in saliva and in tooth biofilm
Time frame: 30 days
1 secondary outcome
Caries incidence reduction
Time frame: Up to 24 months
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 22 Jul 2015.
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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.
Mariana P De Luca, DDs MSc principal investigator
UFMG
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Propolis varnish in people with Streptococcal Infections and Saliva Altered, run by Federal University of Minas Gerais.
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 1 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 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Streptococcus mutans in saliva and in tooth biofilm (time frame: 30 days). 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 22 Jul 2015.