METHODOLOGY :

This study was designed as a double-blind, multi-armed, prospective randomized controlled clinical trial conducted in the Department of Pediatric and Preventive Dentistry and the Department of Microbiology. The target population included pediatric patients aged 6 to 12 years who were undergoing space maintainer therapy, in good general health, and had not used antibiotics or antifungal medications in the past three months. Children with allergies to probiotics or synbiotics, compromised immune systems, or systemic diseases affecting oral health were excluded. After obtaining informed consent, a total of 45 participants were selected and randomly assigned into three equal groups using the lottery method. Group A served as the control and received a placebo containing maltodextrin. Group B received probiotic sachets containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, and Saccharomyces boulardii, while Group C received synbiotic sachets containing the same probiotic strains along with the prebiotic inulin. Participants in the probiotic and synbiotic groups were instructed to dissolve one sachet in a glass of water, gargle the solution for one minute, and swallow it twice daily for a duration of one month. All sachets were packaged in opaque, coded packets to ensure that both participants and investigators were blinded to the group allocations, with a third party responsible for randomization and code maintenance. Clinical assessments were carried out at three time points: baseline, 14 days, and one month. At each visit, plaque accumulation and gingival health were evaluated using standard plaque and gingival indices with the help of a mouth mirror, explorer, and periodontal probe. Saliva samples were collected in sterile cups and immediately transported to the microbiology lab, where they were cultured on Mitis Salivarius agar to assess the Streptococcus mutans count. Plates were incubated aerobically at 37°C for 24 to 48 hours, after which colony-forming units were counted. Data were recorded and analyzed using Microsoft Excel. The normality of the data was tested using the Shapiro-Wilk test. For comparison within each group, the paired t-test was used, while intergroup comparisons were made using ANOVA followed by Post Hoc Tukey’s test. A confidence interval of 95% and a significance level of p < 0.05 were considered statistically significant. This methodology aimed to ensure a rigorous, controlled evaluation of the effectiveness of probiotics and synbiotics in improving oral health in children with space maintainers.