Effect of a Propolis Tablet on the Saliva and the Amount of Adolescent Dental Plaque Microbes
Status:
Completed
Trial end date:
2020-10-21
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Universidade Federal do Rio de Janeiro
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.