Effect of a Propolis Tablet on the Saliva and the Amount of Adolescent Dental Plaque Microbes
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the present study was to evaluate the effect of a xylitol containing propolis
      tablet on the salivary pH, total microorganisms count and soluble and insoluble extracellular
      polysaccharide concentration of the dental biofilm of adolescents in a randomized controlled
      clinical trial. In addition, evaluate the acceptability of the individuals regarding the
      characteristics of the tablets (appearance, taste, aroma and texture) through a
      questionnaire. To that end, healthy adolescents between 10 and 19 years old, without active
      carious lesions, who seek care at the Pediatric Dentistry Clinic of the Universidade Federal
      do Rio de Janeiro (UFRJ) will be randomly assigned to the two groups of the study: control
      group (propolis- consumers of tablets with propolis), respecting an interval of 30 days of
      rest between the consumption of the tablets. The study will be cross-checked and the
      principal investigator will be blind. The tablets will be given to the participants on an
      exact number of days of use and they will be instructed to consume two tablets per day for 7
      uninterrupted days. After 30 days of interval, they will consume the other type of tablet
      with the same recommendations of the first one. The total non-stimulated saliva collection
      will be performed at the beginning of the study (before the consumption of the tablets) and 7
      days after the intervention of each type of tablet, as well as the collection of the dental
      biofilm. Saliva and biofilm samples from all individuals will be identified and later
      analyzed in the laboratory, on the same day of collection, to measure the salivary pH, with
      the aid of a phmeter, and evaluation of the growth of total microorganisms (CFU / mg biofilm
      ), respectively. From the biofilm collected and stored in saline, concentrations of soluble
      and insoluble extracellular polysaccharides will also be measured by means of a
      spectrophotometer. Statistical tests will be used to compare the groups, with a significance
      level of 5%. As results, the propolis-containing tablet is expected to increase the salivary
      pH and decrease the number of total microorganisms in the dental biofilm.
    

Detailed description: 
      Test tablets (with xylitol and propolis) and control (xylitol only) will be offered in an
      exact number of days of use to be consumed orally. Collection of total non-stimulated saliva
      and dental biofilm will be performed at the beginning of the study (before tablet
      consumption) and 7 days after the intervention. Saliva samples from each individual will be
      collected in separate containers as well as the biofilm samples, both at baseline and after 7
      days, for both types of pellets and both tests. All individuals (n=300) will use the tablet
      with and without propolis, respecting interval of 30 days without consumption of any other
      tablet or substance containing propolis and/or xylitol.
    

Intervention name(s): Propolis tablet to limit dental biofilm; Xilytol tablet to limit dental biofilm
Intervention type(s): Drug; Drug
Intervention description(s): The tablets will be offered in an exact number of days of use. Collection of total stimulated saliva and dental biofilm will be performed at the beginning of the study (before tablet consumption) and 7 days after the intervention. Saliva samples from each individual will be collected in separate containers as well as the biofilm samples, both at baseline and after 7 days; The tablets will be offered in an exact number of days of use. Collection of total stimulated saliva and dental biofilm will be performed at the beginning of the study (before tablet consumption) and 7 days after the intervention. Saliva samples from each individual will be collected in separate containers as well as the biofilm samples, both at baseline and after 7 days.
Other intervention name(s): Propolis+Xylitol tablet; Xylitol tablet
Intervention MeSH terms: Propolis
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Clinical trial of prevention, cross, blind, randomized controlled with two arms in the study phase 2-3.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Propole; Xylitol; Saliva