Efficacy of Propolis Varnish Against Oral Biofilm

NCT02052973 | Completed Phase 1

• 1 other identifier: 10726612.8.0000.5149
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Streptococcal Infections; Saliva Altered

Keywords

Streptococcus mutans; Natural products

Outcome Measures

Primary Outcomes (1)

• Streptococcus mutans in saliva and in tooth biofilm

  30 days

Secondary Outcomes (1)

• Caries incidence reduction

  Up to 24 months

Study Arms (1)

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.

Other: Propolis varnish

Interventions

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.

Propolis varnish

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Patients in medical treatment or who used drugs (especially antibiotics), in the three previous weeks and patients with active caries lesions.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Mariana P De Luca, DDs MSc

  UFMG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MSc, PhD student

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: February 3, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 22, 2015

Record last verified: 2015-07