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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
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Streptococcal Infections focused on measuring Streptococcus mutans, Natural products

Eligibility Criteria

8 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

    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
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    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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