Caries Dental
Conditions
Interventions
Action of chewable tablets was determined based on: Red Propolis 2.5% (GROUP I)
Red Propolis 6.4% (GROUP II), Xylitol 15% (GROUP III), and placebo (GROUP IV).
A total of 40 healthy volunteers with caries of both sexes, distributed in 10 for each group, aged between 5 and 12 years
Drug
G07.203.300.140
Sponsors
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Associação Educacional e Cultural de Quixadá
Eligibility
Age
5 Years to 12 Years
Inclusion criteria
Inclusion criteria: Children of both sexes; No history of allergic reactions; Aged between 5 and 12 years; With normal pattern of growth and development; Patients who have not undergone dental treatment during the last six months; Children with caries (presence of at least one lesion of active caries, cavitated or not cavitated).
Exclusion criteria
Exclusion criteria: Patients with a history of allergies (asthma, urticaria, rhinitis, sinusitis); Patients with a history of allergies to medicines, foods or other factors; Patients with a history of chronic diseases, congenital or any systemic alterations; Patients with a history of gastrointestinal, hepatic or renal disease; Patients who have undergone antibiotic treatment up to six months prior to the survey; Patients with soft tissue lesions in the oral cavity; Patients whose parents or legal guardians refuse to sign the free and informed consent form; Children free of carious lesions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the variations in the amount of S. mutans / mL of saliva of each patient by quantifying the Colony Forming Units per milliliter (CFU / mL) before and after the use of the pellets.;Use chewable tablets of natural products in pediatric patients with the purpose of controlling caries disease through a possible antimicrobial activity. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the action of the chewable tablet containing Red Propolis and Xylitol in reducing the levels of Streptococcus mutans in saliva of children with caries, verify the load reduction in CFU / mL.;To compare four groups of children with caries, who will use chewable tablets containing 2.5% Red Propolis (Group I) containing Red Propolis 6.4% (Group II), Xylitol 15% (group III) and Group IV, without Xylitol and without Red Propolis (placebo) by statistical analysis.;To assess the safety of chewing gum containing Xylitol and Red Propolis by investigating adverse events.;The log transformation for the number of CFUs / mL of the dilutions will be used in order to homogenize the variances and make the distribution close to normal. Equation: y = log 10 (x + 1) = log (x + 1). The logarithmic function is defined only for x> 0, since there are values equal to zero, adding 1 to x. The quantitative variables will initially be analyzed by the Kolmogorov-Smirnov test to verify the normality of the distribution. For descriptive statistics, the mean and standard deviation (parametric data) or the median, interquartile range and minimum and maximum values (non-parametric data) shall be calculated. Intergroup comparisons at each stage of the study will be performed using analysis of variance (ANOVA) associated with the Tukey multiple comparisons test to verify differences between groups two to two (parametric data), or the associated Kruskal-Wallis test to Dunn's multiple comparison test (non-parametric variables). Comparisons between the study phases in the same group (intragroup analysis) will be made by repeated measures analysis of variance (ANOVA) associated with the Tukey multiple comparison test (parametric data) or the Friedman test associated with the Dunn multiple comparisons test (non-parametric variables). Nominal qualitative variables will be expressed as absolute and relative frequency and analyzed by Fisher's exact test or the chi-square test. Ordinary qualitat | — |
Countries
Brazil
Contacts
Public ContactEdmir Fraga
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Outcome results
None listed