Trial record 3 of 45 for:    Open Studies | "Streptococcal Infections"

Efficacy of Propolis Varnish Against Oral Biofilm

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Federal University of Minas Gerais
Sponsor:
Collaborators:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Mariana Passos De Luca, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT02052973
First received: January 29, 2014
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Streptococcal Infections
Saliva Altered
Other: Propolis varnish
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of Brazilian Green Propolis Varnish Against Streptococcus Mutans in Saliva and Oral Biofilm: a Phase II Study.

Resource links provided by NLM:


Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • Streptococcus mutans in saliva and in tooth biofilm [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Caries incidence reduction [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: February 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propolis varnish
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.
Other: Propolis varnish
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.

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 % .

  Eligibility

Ages Eligible for Study:   8 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02052973

Contacts
Contact: Mariana P De Luca, DDs, MSc 55 31 8467-5371 delucamariana@hotmail.com
Contact: Vagner R Santos, PHD 55 31 3409-2497 vegneer2003@yahoo.com.br

Sponsors and Collaborators
Federal University of Minas Gerais
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Mariana P De Luca, DDs MSc UFMG
  More Information

No publications provided

Responsible Party: Mariana Passos De Luca, DDS, MSc, PhD student, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02052973     History of Changes
Other Study ID Numbers: 10726612.8.0000.5149
Study First Received: January 29, 2014
Last Updated: January 31, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Minas Gerais:
Streptococcus mutans
Biofilm
Natural products

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Propolis
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014