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Completed

NCT Number: NCT02052973

Efficacy of Propolis Varnish Against Oral Biofilm

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.

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Key information

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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 % .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propolis varnish

Other

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 outcomes

  1. Streptococcus mutans in saliva and in tooth biofilm

    Time frame: 30 days

Secondary outcomes

  1. Caries incidence reduction

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

Efficacy of Brazilian Green Propolis Varnish Against Streptococcus Mutans in Saliva: a Phase II Study.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 3, 2014
Registry last updated
Jul 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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