Impact of a Novel Oral Health Tracker cum Motivator Versus Conventional Education on Oral Health Behavior Among 10- to 15-Year-Old School Children in Lucknow: A Single-Blinded, Parallel Design-A Randomized Controlled Trial.

Aim: Oral health plays a crucial role in overall well-being, particularly during childhood when positive habits are best established. Despite ongoing efforts, traditional oral health education methods often fall short in effectively influencing long-term behavior change. This study aimed to evaluate the effectiveness of a novel oral health tracker cum motivator (OHTM) in comparison to conventional educational methods for improving oral health behaviors among school-aged children in Lucknow. Materials and Methods: In a single-blinded, parallel design, and RCS, 64 children were randomly assigned (computer-generated sequence; opaque sealed envelopes) to either the experimental group (OHTM) or the control group (traditional education). "Single-blinded" refers to outcome assessors being unaware of group allocation. Sample size was calculated using G*Power 3.1.9.7 for 80% power, α = 0.05, and effect size d = 0.31, based on Kumar et al. (2015). Baseline and follow-up assessments at 2 months used a 15-item theory of planned behavior (TPB)-based questionnaire and the debris index (oral hygiene index-simplified). Primary outcomes were pre-specified as knowledge scores and debris scores; no secondary outcomes were registered. Statistical analyses included paired and independent t tests, repeated measures analysis of variance, effect sizes (Cohen's d), and 95% confidence intervals (CI). Results: Post-intervention analysis revealed that the experimental group demonstrated a significantly greater improvement in both clinical and behavioral outcomes. Debris scores in the experimental group reduced from 2.06 ± 0.43 to 1.26 ± 0.36 (95% CI: -1.00 to -0.60; P = 0.017; d = 0.64), while the control group showed a reduction from 2.03 ± 0.48 to 1.48 ± 0.35 (95% CI: -0.77 to -0.33; P = 0.017). Knowledge scores improved from 9.09 ± 2.40 to 11.50 ± 1.48 in the experimental group (95% CI: 1.47-3.35; P = 0.002; d = 0.82), compared to 8.63 ± 1.77 to 10.34 ± 1.41 in the control group (95% CI: 0.98-2.44; P = 0.002). Conclusion: The findings highlight that the OHTM significantly improved oral hygiene and knowledge compared to traditional methods. Interactive, theory-based tools showed more engagement and sustained behavior change, aligned with social cognitive theory, and the TPB. These findings suggest that such tools may be scalable in school health programs. The trial is registered with the Clinical Trials Registry-India (CTRI) under registration number CTRI/2025/03/082764.