Efficacy of Propolis Varnish Against Oral Biofilm
Primary Purpose
Streptococcal Infections, Saliva Altered
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Propolis varnish
Sponsored by
About this trial
This is an interventional prevention trial for Streptococcal Infections focused on measuring Streptococcus mutans, Natural products
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients in medical treatment or who used drugs (especially antibiotics), in the three previous weeks and patients with active caries lesions.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Propolis varnish
Arm Description
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.
Outcomes
Primary Outcome Measures
Streptococcus mutans in saliva and in tooth biofilm
Secondary Outcome Measures
Caries incidence reduction
Full Information
NCT ID
NCT02052973
First Posted
January 29, 2014
Last Updated
July 20, 2015
Sponsor
Federal University of Minas Gerais
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT02052973
Brief Title
Efficacy of Propolis Varnish Against Oral Biofilm
Official Title
Efficacy of Brazilian Green Propolis Varnish Against Streptococcus Mutans in Saliva: a Phase II Study.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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 % .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Streptococcal Infections, Saliva Altered
Keywords
Streptococcus mutans, Natural products
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propolis varnish
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Propolis varnish
Intervention Description
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.
Primary Outcome Measure Information:
Title
Streptococcus mutans in saliva and in tooth biofilm
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Caries incidence reduction
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Patients in medical treatment or who used drugs (especially antibiotics), in the three previous weeks and patients with active caries lesions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana P De Luca, DDs MSc
Organizational Affiliation
UFMG
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Propolis Varnish Against Oral Biofilm
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